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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 pancreatic stent, covered, metallic, removable
De Novo Number DEN130007
510(K) Number K123250
Device Name AXIOS STENT AND DELIVERY SYSTEM
Requester
XLUMENA, INC
453 ravendale drive,
suite h
moutain view,  CA  94043
Contact jane beggs
Regulation Number876.5015
Classification Product Code
PCU  
Date Received02/19/2013
Decision Date 12/18/2013
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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