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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, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
510(k) Number K121754
FOIA Releasable 510(k) K121754
Device Name BLUE SUI SLING
Applicant
Boston Scientific Corp
100 Boston Scientific Way
M21
Marlborough,  MA  01752
Applicant Contact JANET A MCGRATH
Correspondent
Boston Scientific Corp
100 Boston Scientific Way
M21
Marlborough,  MA  01752
Correspondent Contact JANET A MCGRATH
Regulation Number878.3300
Classification Product Code
OTN  
Date Received06/14/2012
Decision Date 10/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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