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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 K151197
Device Name Lariat snare
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY ROAD
MENTOR,  OH  44060
Applicant Contact SAGAR PIMPALWAR
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY ROAD
MENTOR,  OH  44060
Correspondent Contact SAGAR PIMPALWAR
Regulation Number876.4300
Classification Product Code
FDI  
Date Received05/05/2015
Decision Date 07/06/2015
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
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