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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, stress urinary incontinence
510(k) Number K172565
Device Name Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Anand Patel
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Anand Patel
Regulation Number884.4910
Classification Product Code
PWJ  
Date Received08/25/2017
Decision Date 12/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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