FDA 510(k) Application Details - K220641

Device Classification Name	More FDA Info for this Device
510(K) Number	K220641
Device Name	Barrigel Injectable Gel
Applicant	Palette Life Sciences 27 East Cota Street, Suite 402 Santa Barbara, CA 93101 US Other 510(k) Applications for this Company
Contact	David Goodnough 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	03/04/2022
Decision Date	05/26/2022
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