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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K140315
Device Name US ENDOSCOPY DISTAL ATTACHMENT CAP
Applicant
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact SAGAR D PIMPALWAR
Correspondent
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact SAGAR D PIMPALWAR
Regulation Number876.1500
Classification Product Code
OCX  
Date Received02/10/2014
Decision Date 04/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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