FDA 510(k) Application Details - K181330

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K181330
Device Name	Dressing, Wound, Collagen
Applicant	NeXtGen Biologics, Inc. 747 SW 2nd Ave - IMB 5 Gainesville, FL 32601 US Other 510(k) Applications for this Company
Contact	Jonelle L. Toothman 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	05/18/2018
Decision Date	10/11/2018
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