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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name stimulator, peripheral nerve, non-implanted, for urinary incontinence
De Novo Number DEN000002
510(K) Number K992069
Device Name UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
Requester
UROSURGE, INC.
2660 crosspark rd.
coralville,  IA  52241
Contact steven j preiss
Regulation Number876.5310
Classification Product Code
NAM  
Date Received01/27/2000
Decision Date 02/09/2000
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
Type Post-NSE
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