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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K926104
Device Name POLYP NET
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 Number876.1500
Classification Product Code
GCJ  
Date Received12/03/1992
Decision Date 04/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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