FDA 510(k) Application Details - K213498

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K213498
Device Name	Dressing, Wound, Collagen
Applicant	Gunze Limited 46 Natsumegaichi, Aono Ayabe, Kyoto 623-8513 JP Other 510(k) Applications for this Company
Contact	Hidenori Nishioka 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	11/01/2021
Decision Date	07/14/2022
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