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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 K061333
Device Name URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
Applicant
Uroplasty, Inc.
2718 Summer St. NE
Minneapolis,  MN  55413 -2820
Applicant Contact LISA GALLATIN
Correspondent
Uroplasty, Inc.
2718 Summer St. NE
Minneapolis,  MN  55413 -2820
Correspondent Contact LISA GALLATIN
Regulation Number876.5310
Classification Product Code
NAM  
Date Received05/12/2006
Decision Date 07/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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