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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K926103
Device Name POLYP SNARE NET W/MONOPOLAR CAUTERY
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 Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
GCJ  
Date Received12/03/1992
Decision Date 09/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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