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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, biopsy, mechanical, gastrointestinal
510(k) Number K915142
Device Name AMCATH DISPOSABLE BIOPSY FORCEPS
Applicant
INTL. MEDICAL, INC.
175 CONNECTICUT MILLS AVE.
DANIELSON,  CT  06239
Applicant Contact PETER WETTERMANN
Correspondent
INTL. MEDICAL, INC.
175 CONNECTICUT MILLS AVE.
DANIELSON,  CT  06239
Correspondent Contact PETER WETTERMANN
Regulation Number876.1075
Classification Product Code
FCF  
Date Received11/14/1991
Decision Date 01/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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