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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 K250066
Device Name Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  02472
Applicant Contact Kyra McNamara
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  02472
Correspondent Contact Kyra McNamara
Regulation Number876.4400
Classification Product Code
PKL  
Date Received01/10/2025
Decision Date 02/06/2025
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
Predetermined Change
Control Plan Authorized		 No
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