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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 K020110
Device Name MODIFICATION TO TRELEX MESH SURGICAL MESH
Applicant
Boston Scientific
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact DONNA M GARDNER
Correspondent
Boston Scientific
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact DONNA M GARDNER
Regulation Number878.3300
Classification Product Code
OTN  
Date Received01/11/2002
Decision Date 04/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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