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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 K053296
Device Name MENTOR ARIS SUPRAPUBIC SURGICAL KIT
Applicant
MENTOR CORPORATION
201 MENTOR DRIVE
SANTA BARBARA,  CA  93111
Applicant Contact DONNA A CRAWFORD
Correspondent
MENTOR CORPORATION
201 MENTOR DRIVE
SANTA BARBARA,  CA  93111
Correspondent Contact DONNA A CRAWFORD
Regulation Number878.3300
Classification Product Code
OTN  
Date Received11/25/2005
Decision Date 12/15/2005
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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