FDA 510(k) K132561, NURO NEUROMODULATION SYSTEM, by Advanced Uro-Solutions, Inc.
FDA 510(k) K132561, NURO NEUROMODULATION SYSTEM, by Advanced Uro-Solutions, Inc.
Device Classification Name: Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
510(k) Number: K132561
Device Name: NURO NEUROMODULATION SYSTEM
Applicant: Advanced Uro-Solutions, Inc.
Regulation Number: 876.5310
Classification Product Code: NAM
Date Received: 08/15/2013
Decision Date: 11/05/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 806
Fully redacted pages: 464
Content pages: 342
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