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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K970945
Device Name ANGLED TIP POLYPECTOMY SNARE
Applicant
United States Endoscopy Group, Inc.
9330 Progress Pkwy.
Mentor,  OH  44060
Applicant Contact GRETCHEN YOUNKER-COHEN
Correspondent
United States Endoscopy Group, Inc.
9330 Progress Pkwy.
Mentor,  OH  44060
Correspondent Contact GRETCHEN YOUNKER-COHEN
Regulation Number876.4300
Classification Product Code
KNS  
Date Received03/14/1997
Decision Date 05/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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