FDA 510(k) Application Details - K233378

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K233378
Device Name	Dressing, Wound, Collagen
Applicant	ACRO Biomedical Co., Ltd. 3F., No.57, Luke 2nd Rd., Lujhu Dist. Kaohsiung City 82151 TW Other 510(k) Applications for this Company
Contact	Dar-Jen Hsieh 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	10/02/2023
Decision Date	10/18/2024
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