FDA 510(k) Application Details - K182971

Device Classification Name	More FDA Info for this Device
510(K) Number	K182971
Device Name	SpaceOAR Vue Hydrogel
Applicant	Augmenix, Inc 21 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	10/26/2018
Decision Date	07/19/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review