FDA 510(k) Application Details - K220286

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K220286
Device Name	Dressing, Wound, Drug
Applicant	V3bio Sdn. Bhd No 18 Jalan Cassia Selatan 3/1 Taman Perindustrian Batu Kawan Bandar Cassia Simpang Ampat 14100 MY Other 510(k) Applications for this Company
Contact	Shudipta Choudhury 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	02/01/2022
Decision Date	12/21/2022
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