FDA 510(k) Application Details - K223914

Device Classification Name	More FDA Info for this Device
510(K) Number	K223914
Device Name	ACTIVÖ Cap
Applicant	Cleansite Medical, Inc. 125 Highway 101 Solana Beach, CA 92075 US Other 510(k) Applications for this Company
Contact	Neal Hartman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2022
Decision Date	04/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review