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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 hydrogel spacer
De Novo Number DEN140030
Device Name SpaceOAR System
Requester
AUGMENIX , INC.
204 second avenue
lower level
waltham,  MA  02451
Contact noel rolon
Regulation Number892.5725
Classification Product Code
OVB  
Date Received10/01/2014
Decision Date 04/01/2015
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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