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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Punch, Biopsy
510(k) Number K853104
Device Name DISPOSABLE, STERILE BIOPSY PUNCH
Applicant
August C. Stiefel Research Institute, Inc.
Oakhill,  NY  12460
Applicant Contact WILLIAM A CARR
Correspondent
August C. Stiefel Research Institute, Inc.
Oakhill,  NY  12460
Correspondent Contact WILLIAM A CARR
Regulation Number876.1075
Classification Product Code
FCI  
Date Received07/23/1985
Decision Date 10/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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