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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pancreatic Stent, Covered, Metallic, Removable
510(k) Number K140561
Device Name AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
Applicant
Xlumena, Inc.
453 Ravendale Dr., Suite H
Mountain View,  CA  94043
Applicant Contact JANE BEGGS
Correspondent
Xlumena, Inc.
453 Ravendale Dr., Suite H
Mountain View,  CA  94043
Correspondent Contact JANE BEGGS
Regulation Number876.5015
Classification Product Code
PCU  
Date Received03/05/2014
Decision Date 04/23/2014
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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