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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 K101440
Device Name GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
Applicant
Generic Medical Devices, Inc.
P.O. Box 818
Ocean Shores,  WA  98569
Applicant Contact JEFF MORGAN
Correspondent
Generic Medical Devices, Inc.
P.O. Box 818
Ocean Shores,  WA  98569
Correspondent Contact JEFF MORGAN
Regulation Number878.3300
Classification Product Code
OTN  
Date Received05/24/2010
Decision Date 06/18/2010
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
Predetermined Change
Control Plan Authorized		 No
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