Your Sterilizer Experts Manufacturing ndash Distribution ndash Maintenance- Guaranteed

Alfa Medical 1-800-762-1586

265 Post Ave 516-280-7822

Westbury NY 11590 516-280-7832 fax

wwwsterilizerscom

eMailsterilizerscom

The attached manual is for your records

Go to the below web site to look for parts

httpbitlyAll-American-Sterilizer-Parts

180781 180787

act or because the COmmissioner has found under section 510(g)(4) of the act that such reg1stration is not necshyeasary for the protection of the publichealth

(a) A manufacturer of raw mater1als or components to be used in the manushyfacture or assembly of a device who would otherwise not be required to regshyister under the provisions of this part

(b) A manutacturer of devices to be used solely for veter1nary purposes

(c) A manutacturer of general purshypose articles such as ohemtoal reagents or laboratory equipment whose uses are generally known by persons trained in their use and whioh are not labeled or promoted for medioal uses

(d) Licensed practitioners includinS Physic1ans dentists and optometrists who manufacture or otherwise alter deshyvioes solely for use in their practice

(e) Pharmacies sur81oal supply outshylets or other s1m11ar reta11 establishshyments making f1naJ delivery or we to the ultimate user This exemption also applies to a pharmaoy or other s1m1lar retail establishment that purchases a device for subsequent distribution under its own name eg a properly lashybeled health aid such as an elastic banshydage or crutch indicatinB distributed by or manufactured for followed by the name of the pharmacy

(pound) Persons who manufacture preshyPIL18 propagate compound or process devices solely for use in research teachinB or analysis and do not introshyduce such devices into commeroial disshytribution

(g) [Reserved1 (h) Carriers by reason of their reshy

ceipt carriage hoIdinS or delivery of devices in the usUal course of bUSiness as oarriers

(i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service neceasary to provide the consumer (ie patient physician layman eto) with a device or the benefits to be derived from the use of a devioe for example a hear1ng aid dispenser optiCian clinioal laboratory assembler of diaBnostic xshyray systemll and personnel from a hosshypital olinic dental laboratoryorthotic or prosthetic retail facUity whose pr1mary responstbWty to the ulshytimate consumer is to dispense or proshy

21 en Ch I (4-1-95 EdItIon)

vide a service throUBh the use of a preshyviously manufactured device [42 FR 42526 Aug lIS 1917 as amended at 68 FR 46523 Sept 1 1998]

Subpart E-Premarket Notification Procedures

180781 When a preIIIIUkef DOtiflcatioJl nbuton required

(a) Except as provided in paragraph (b) of this seotion each person who is required to repter his establishment pursuant to 180720 must submit a preshymarket not111cat1on submission to the Food and Druamp Administration at least 90 davB before he proposes to beB1n the introduction or delivery for introducshytion into interstate commerce for comshymero1al distribution of a device inshytsnded for human use which meets anyof the follow1nB criteria

(1) The device is be1nB introduced into commeroial distribution for the first time that is the device is not of the same type as or is not subatanshytially equivalent to (i) a device in commeroial distribution before May 28 1916 or (11) a device introduced for oommeroial distribution after May 28 1976 that has subsequently been reo1asshysified into class I or n

(2) The device is be1nB introduced into oommeroial distribution for the first time by a person required to regshyister whether or not the device meets the criteria in parag-raph (a)(I) of this seotion

(S) The device is one that the person currently has in commercial distribushytion or is reintroduoing into commershycial diStribution but that is about to be BiBnificantly ohanged or modifled in desiBn oomponents method of manushyfacture or intended use The follow1DB constitute BiBnificant changes or modishyfications that require a premarket noshytification

(i) A chaDge or modification in the device that co1ild BiBnificantly atIect the safety or effectiveness of the deshyvice eg a BiBnificant ohanBe or modishyfication in des1p mater1al chemical oomposition energy source or manushyfacturing process

(11) A major chaDge or modiflcation in the intended use of the device

(b) A premarket notification under this subpart is not required for a device

Food and Drug AcImInIItraIIon HHS

for which a premarket approval applishycation under section 515 of the act or for which a petition to reclass1ty under

section 518(pound)(2) of the act is pendinS before the Food and Drag Administrashytion

(c) In addition to comPlv1nB with the requirements of this part owners or operators of device establishments that manufacture radtation-emttting elecshytronio products as defined in sect1000S of this chapter shall oomply with the reshyporting requirements of Part 1002 of this ohapter

180781 Blremptlon from pnmarket DOtHlcatiOll

(a) A devioe is exempt from the preshymarket notification requirements of this subpart if the device intended for introduotion into oommeroial distribushytion is not generally available in finshyished form for purchase and is not ofshyfered throUBh labellDB or advertis1Dgby the manufacturer Importer or disshytributor thereof for commeroiaJ disshytribution and the device meets one of the following conditions

(1) It is intended for use by a patient named in the order of the phys101sD or dentist (or other specially quaJtfied person) or

(2) It is intended solely for use by a physio1an or dentist (or other specially quaJtfied person) and is not generally available to or generally used by other physio1ans or dentists (or other specially qual1fied persons)

(b) A distributor who places a device into oommero1al distribution for the first time under his own name and a repaokager who places his own name on a devioe and does not ohaDge any other labellDB or otherwise atIeot the device shall be exempted from the preshymarket notification requirements of this subpart if

(1) The device was in commeroial disshytribution before May 28 1916 or

(2) A premarket notification submisshysion was rued by another person

180787 IDfonaatioJl reqalrecllD a preshyIIl8IUt DOWieatioD Inibm_lou

Each premarket notification submisshysion shall contain the followiDB inforshymation

(a) The device name inclUding both the trade or proprietary name and the

common or usual name or classificashytion name of the device

(b) The establ1shment r8Bistration number if applicable of the owner or operator submttt1nB the premarket noshytification submtssion

(c) The class in whioh the devioe has been put under section 513 of the act and if known its appropriate panel or if the owner or operator determines that the device has not been classified under such section a statement of that determination and the basis for the persons determination that the device Is not so classified

(d) Action taken by the person reshyquired to reBister to comply with the requirements of the act under section 514 for performance standardB

(e) Proposed labels label1nB and adshyvertisements sufficient to describe the device its intended use and the direcshytions for its use Where applicable phoshytographs or enBineering drawingS should be supplied

(pound) A statement indicating the devioe is s1m11ar to andor different from other products of comparable oP8 in commeroial distribution accompanied by data to support the statement This information may include an identificashytion of s1m11ar produots materials deshySip oonsiderations enerBY expected to be used or delivered by the device and a description of the operational prinshyoiples of the device

(g) Where a person required to regshyister intends to introduce into oomshymeroial distribution a device that has undergone a sign1f1cant chaDge or modification that could sipifioantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use the premarket notification subshymission must include appropriate supshyport1nB data to show that the manufacshyturer has considered what conshysequences and effects the ohange or modification or new use mtght have on the safety and effectiveness of the deshyvice

(h) A 61O(k) summary as described in sect80792 or a 510(k) statement as deshyscr1bed in 180798

(1) For submiSSiOns ola1m1ngsubetanshytial equivalence to a device which has been classified into olass m under secshytion 513(b) ofthe act

ALL - AMERICAN gtortable

STEAM PRESSURE

Sterilizer eAST AWMfNUM DUll GAUOE AN CONlitltllCTION VAlll COfCTllOl

STAMID ALUMINUM MEIAL TO M8Al SIAL SEAMUSS INS CONTAINEJ (No avWNr Co-ofIJ

WY TO ClEAH lAAOI

CAS1 ALUMINUM STIIU Z CAPAClIY ClLAlI lAC(

COMJLamp1I AND iliCTlVe flUlttl MlfA EXHAUST SIUIUZAnOH AT THI

lUle lOWltl posSallco

ALL-AMERICAN Sterilizers mak it pouibl or aU doctor dentiats fint aid stations hoPitallt and 1aboratori~ to have fool-ptoOf aterllization facilities

at an extremely low cost Used over a1ly effective heet source it ia only a matter of minutes to secure dry sterile dr_np and instrum6ts with all bacteria and micro-orranlsms destroyed Only a small amount of water is Deeded and the dry tttam at 20 lbt pressure penetrates all binges aod crevasses i~ any instrument and makes them sterile in 15 to 20 minutu Nc wiping is nec_ry to remove chemical residue or moisture IUld cutting edges are n01 dulled

Dressings 191e made stlMile in about 30 minutes and ready lor Immediatcent use

THREE POPULAR SIZES Nbullbull It)U~-)( (15 qt liquid cap) SIMp Wt 20 ut No 1925-X (25 qt hquld ap) Ship Wt 25 bullbullbull

No 1941~X (4Ht qt liquid I1Ip) Ship Wt 39 I

Each ~u-- peclnrcl I indlhbbullbulll COnl9111ec1 cadlgtU

Th AJIAMERICAN Stllrillers ltliTeuro math oi hiah QUAlity lt$81 aluminum alloy with n the ap~eial CeatUres or the famous ALL-AMERICAN PreSlllr~

Craquookers The meblJto-mlllltal seal eliminates all rubshyber lasleets and 1he ciampina lQCks prevent rvmoval

01 the cover while thlllllQ Is p1lot$Suce pN$enl af a safety feature An accurate prlssuca Raup tilt~ fOI

easy Ieadinc pr4lSSut~ conte-oJ valve and oVIT-presmiddot

sure $Qfety plug metal air lease tUbing for qukl(

exhawstioR of all air within th~ Steriljlaquor and cool bakelite nandle and winK nut51 nee aU thoroulI-hlJmiddot

tested features that assurft yenlte fool-proof orxratior

with a minimum amount of attentiun

bullbull Please email or call for any additional information you may need infosterilizerscom 1(800)762-1586

--

6054

2157

~-- __- _ -- ALe -Ar1ER H~1~N S I E1IT[TZERS_____

-- shyJOBBERS PRICE LIST - EFFECTIVE APRIL (S 1976

~

ITEM OEseR I PTt ON

STO~NQ -

CAST STpoundRILIZER 1St qt lJquTd cap_

UN I T PR iCE

~ 3~ 25

RECOMMENDED RETA IL PRICE

$ -05 90 - I

CAST STER ft rZER 25 qt irqutd cap 4285 1 7790

middotmiddot192SXmiddot

-lt

UN tT ~stFfING PACK ~WEIGl-tT

20 1bs

25 Tbs

CAST STERUZER bull f41 qt liqufd cap r

I 79bull 15 1

143 90 f 42 lbs

t

25x-rOV t ELECTRIC STEROCLAVE

I f I110 VOLTS j

831 Cubic Inches Cap 103 95 f8900 r 30 lbsI 2SX-220V

NSTALlATI ON OF 6054

ELECTRIC STEROCLAVE 220 VOLTS 831 Cubic lnenes Cap

THERMOMETER Stainless Steel 500 - 3000

THERMOMETER rNSTALlED AT FACTORY

GROUNDED 3 WIRE ELECTR I C CORD AND PLUG

10725

rO95

880

435

i

I 195 00

1990

1600

7 90

I SO 1bs

I 12 oz

r

I 14 OZbull

FREIGHT TERMS FOB FACTORY rN ANY QUANTlTY

PRICES SUBJECT TO CHANGE WITHOUT NOTfCE p

Please note that above prices are from 1976 and are only for demonstration purposes Please email or call for any additional information you may need infosterilizerscom 1-(800)762-1586