FDA 510(k) Application Details - K213598

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K213598
Device Name	Dressing, Wound, Collagen
Applicant	Huizhou Foryou Medical Devices CO., Ltd. No.1 Shangxia North Road, Dongjiang Hi-tech Industry Park Huizhou 516000 CN Other 510(k) Applications for this Company
Contact	Taylor Deng Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2021
Decision Date	09/20/2022
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