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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, For Stress Urinary Incontinence, Male
510(k) Number K211847
Device Name AdVance XP Male Sling System
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Malborough,  MA  01752
Applicant Contact Anuja Bhatt
Correspondent
Boston Scientific Corporation
300 Boston Scientific Way
Malborough,  MA  01752
Correspondent Contact Anuja Bhatt
Regulation Number878.3300
Classification Product Code
OTM  
Date Received06/15/2021
Decision Date 12/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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