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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K092221
Device Name COLONIC SPLINTING OVERTUBE, MODEL 00711145
Applicant
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact CRAIG L MOORE
Correspondent
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact CRAIG L MOORE
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/22/2009
Decision Date 10/20/2009
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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