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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Non-Electric
510(k) Number K840818
Device Name BIOPSY FORCEPS
Applicant
AMERICAN ENDOSCOPY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN ENDOSCOPY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.1075
Classification Product Code
FCL  
Date Received02/24/1984
Decision Date 04/13/1984
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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