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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 K991276
Device Name PASS/FAIL CHALLENGE PACK
Applicant
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Applicant Contact JOHN D DYCKMAN
Correspondent
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Correspondent Contact JOHN D DYCKMAN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/14/1999
Decision Date 07/12/1999
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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