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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 K122660
Device Name RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Applicant
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact THOMAS HIRTE
Correspondent
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact THOMAS HIRTE
Regulation Number876.4400
Classification Product Code
PKL  
Date Received08/31/2012
Decision Date 12/03/2012
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
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