FDA 510(k) Application Details - K230980

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K230980
Device Name	Dressing, Wound, Collagen
Applicant	ACell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia, MD 21046 US Other 510(k) Applications for this Company
Contact	Simone Oliver 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	04/05/2023
Decision Date	09/22/2023
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