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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K851804
Device Name BIO-CHALLENGE TEST PAK
Applicant
Propper Mfg. Co., Inc.
3604 Skillman Ave.
Long Island City,  NY  11101
Applicant Contact JOHN DYCKMAN
Correspondent
Propper Mfg. Co., Inc.
3604 Skillman Ave.
Long Island City,  NY  11101
Correspondent Contact JOHN DYCKMAN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/30/1985
Decision Date 07/16/1985
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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