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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
510(k) Number K172060
Device Name Capio SLIM Suture Capturing Device
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Rachel Nankervis
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Michelle Becker
Regulation Number884.4910
Classification Product Code
PWI  
Date Received07/07/2017
Decision Date 11/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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