FDA 510(k) Application Details - DEN140030

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140030
Device Name	SpaceOAR System
Applicant	AUGMENIX , INC. 204 SECOND AVENUE LOWER LEVEL WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	Noel Rolon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2014
Decision Date	04/01/2015
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review