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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hemostatic metal clip for the gi tract
510(k) Number K102764
Device Name RESOLUTION II CLIP
Applicant
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact ELENA NIEVES
Correspondent
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact ELENA NIEVES
Regulation Number876.4400
Classification Product Code
PKL  
Date Received09/24/2010
Decision Date 12/22/2010
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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