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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 K040787
Device Name MODIFICATION TO SURGICAL MESH POLYMERIC
Applicant
BOSTON SCIENTIFIC
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact DONNA M GARDNER
Correspondent
BOSTON SCIENTIFIC
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact DONNA M GARDNER
Regulation Number878.3300
Classification Product Code
OTN  
Date Received03/29/2004
Decision Date 04/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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