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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 K083471
Device Name GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
Applicant
Generic Medical Device, Inc.
5727 Baker Way NW Suite 201
Gig Harbor,  WA  98332
Applicant Contact MONICA MONTANEZ
Correspondent
Generic Medical Device, Inc.
5727 Baker Way NW Suite 201
Gig Harbor,  WA  98332
Correspondent Contact MONICA MONTANEZ
Regulation Number878.3300
Classification Product Code
OTN  
Date Received11/24/2008
Decision Date 03/03/2009
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
Recalls CDRH Recalls
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