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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K903024
Device Name BI-O.K. STEAM TEST-PAK
Applicant
PROPPER MFG. CO., INC.
3604 SKILLMAN AVE.
LONG ISLAND CITY,  NY  11101
Applicant Contact JOHN D DYCKMAN
Correspondent
PROPPER MFG. CO., INC.
3604 SKILLMAN AVE.
LONG ISLAND CITY,  NY  11101
Correspondent Contact JOHN D DYCKMAN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/10/1990
Decision Date 09/12/1990
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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