FDA 510(k) Application Details - K202224

Device Classification Name	More FDA Info for this Device
510(K) Number	K202224
Device Name	SpaceOAR System
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Jeanne OToole 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	08/07/2020
Decision Date	08/28/2020
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