FDA 510(k) Application Details - K223126

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K223126
Device Name	Dressing, Wound, Collagen
Applicant	Maxigen Biotech, Inc. No. 88, Keji 1st Rd., Guishan District Taoyuan City 333411 TW Other 510(k) Applications for this Company
Contact	Cheng-Han Chou 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	10/03/2022
Decision Date	10/11/2023
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