FDA 510(k) Application Details - K250329

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K250329
Device Name	Dressing, Wound, Collagen
Applicant	GeniPhys, Inc. 7750 Zionsville Road, Suite 200 Indianapolis, IN 46268 US Other 510(k) Applications for this Company
Contact	Sherry Harbin 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	02/05/2025
Decision Date	06/25/2025
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