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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 K160637
Device Name Rotatable Snares
Applicant
BOSTON SCIENTIFIC CORPORATION
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact Michael Secondini
Correspondent
BOSTON SCIENTIFIC CORPORATION
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact Michael Secondini
Regulation Number876.4300
Classification Product Code
FDI  
Subsequent Product Code
FGX  
Date Received03/07/2016
Decision Date 03/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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