FDA 510(k) Application Details - K223259

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K223259
Device Name	Dressing, Wound, Drug
Applicant	Kane Biotech, Inc. 290-100 Innovation Drive Winnipeg R3T6G2 CA Other 510(k) Applications for this Company
Contact	Lori Christofalos Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2022
Decision Date	05/24/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review