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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 K092461
Device Name IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Applicant Contact CRAIG MOORE
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Correspondent Contact CRAIG MOORE
Regulation Number876.1500
Classification Product Code
OCX  
Date Received08/11/2009
Decision Date 11/05/2009
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
Recalls CDRH Recalls
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