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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name snare, flexible
510(k) Number K140763
FOIA Releasable 510(k) K140763
Device Name MONOFILAMENT POLYPECTOMY SNARE
Applicant
UNITED STATES ENDOSCOPY
5976 HEISLEY ROAD
MENTOR,  OH  44060
Applicant Contact SAGAR D PIMPALWAR
Correspondent
UNITED STATES ENDOSCOPY
5976 HEISLEY ROAD
MENTOR,  OH  44060
Correspondent Contact SAGAR D PIMPALWAR
Regulation Number876.4300
Classification Product Code
FDI  
Date Received03/27/2014
Decision Date 04/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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