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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 K972747
Device Name BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
Applicant
PROPPER MFG. CO., INC.
36-04 SKILLMAN AVE.
LONG ISLAND CITY,  NY  11101
Applicant Contact JOHN D DYEKMAN
Correspondent
PROPPER MFG. CO., INC.
36-04 SKILLMAN AVE.
LONG ISLAND CITY,  NY  11101
Correspondent Contact JOHN D DYEKMAN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/23/1997
Decision Date 01/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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