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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 K052025
Device Name URGENT PC NEUROMODULATION SYSTEM
Applicant
Uroplasty, Inc.
2718 Summer St. NE
Minneapolis,  MN  55413
Applicant Contact MICHAEL MORRELL
Correspondent
Uroplasty, Inc.
2718 Summer St. NE
Minneapolis,  MN  55413
Correspondent Contact MICHAEL MORRELL
Regulation Number876.5310
Classification Product Code
NAM  
Date Received07/27/2005
Decision Date 10/17/2005
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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