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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 K961156
Device Name ONCE-A-DAY BOWIE AND DICK TEST PACK.
Applicant
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Applicant Contact THOMAS A AUGURT, PH.D.
Correspondent
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Correspondent Contact THOMAS A AUGURT, PH.D.
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received03/22/1996
Decision Date 04/01/1997
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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