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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K120084
FOIA Releasable 510(k) K120084
Device Name ENDOSCOPIC RETRIEVAL DEVICE
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Applicant Contact ERIC MAYNARD
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Correspondent Contact ERIC MAYNARD
Regulation Number876.1500
Classification Product Code
OCZ  
Date Received01/11/2012
Decision Date 05/30/2012
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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