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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Ethylene-Oxide Gas
510(k) Number K901146
Device Name JOSLYN EO STERILIZER/ EO MODERNIZATION KIT
Applicant
Joslyn Valve Corp.
564 Wilkingon Rd.
Macedon,  NY  14502
Applicant Contact LARRY JOSLYN
Correspondent
Joslyn Valve Corp.
564 Wilkingon Rd.
Macedon,  NY  14502
Correspondent Contact LARRY JOSLYN
Regulation Number880.6860
Classification Product Code
FLF  
Date Received03/12/1990
Decision Date 03/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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