FDA 510(k) Application Details - DEN220087

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220087
Device Name	Edison System
Applicant	HistoSonics, Inc. 16305 36th Avenue N Suite 300 Plymouth, MN 55446 US Other 510(k) Applications for this Company
Contact	Daniel Kosednar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2022
Decision Date	10/06/2023
Decision	DENG -
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review