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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, electric
510(k) Number K925361
Device Name BIOPSY FORCEPS, ELECTRIC
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
7123 INDUSTRIAL PARK BLVD.
MENTOR,  OH  44060
Applicant Contact JOHN WINSTANLEY
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
7123 INDUSTRIAL PARK BLVD.
MENTOR,  OH  44060
Correspondent Contact JOHN WINSTANLEY
Regulation Number876.4300
Classification Product Code
KGE  
Date Received10/22/1992
Decision Date 03/29/1993
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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