FDA 510(k) Application Details - K181465

Device Classification Name	More FDA Info for this Device
510(K) Number	K181465
Device Name	SpaceOAR System
Applicant	Augmenix, Inc. 201 Burlington Road Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Marcus Garcia 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	06/04/2018
Decision Date	06/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review