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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
510(k) Number K071822
Device Name URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
Applicant
Uroplasty, Inc.
5420 Feltl Rd.
Minnetonka,  MN  55343
Applicant Contact LISA GALLATIN
Correspondent
Uroplasty, Inc.
5420 Feltl Rd.
Minnetonka,  MN  55343
Correspondent Contact LISA GALLATIN
Regulation Number876.5310
Classification Product Code
NAM  
Date Received07/03/2007
Decision Date 08/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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