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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 agents, embolic, for treatment of benign prostatic hyperplasia
De Novo Number DEN160040
Device Name Embosphere Microspheres
Requester
biosphere medical, s.a.
a wholly owned subsidiary of merit medical systems inc.
parc des nations-paris nord 2
383 rue de la belle etoile,  FR 95700
Contact alix fonlladosa
Regulation Number876.5550
Classification Product Code
NOY  
Date Received08/05/2016
Decision Date 06/21/2017
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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