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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 temporary coil embolization assist device
De Novo Number DEN170064
Device Name Comaneci, Comaneci Petit, Comaneci 17
Requester
rapid-medical ltd.
carmel building
pob 337
yokneam,  IL 2069205
Contact orit yaniv
Regulation Number882.5955
Classification Product Code
PUU  
Date Received09/28/2017
Decision Date 04/24/2019
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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