FDA 510(k) Application Details - K151083

Device Classification Name	More FDA Info for this Device
510(K) Number	K151083
Device Name	BioBridge Collagen Matrix
Applicant	Fibralign Corporation 32930 Alvarado-Niles Road, Suite 350 Union City, CA 94587 US Other 510(k) Applications for this Company
Contact	Greg King Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2015
Decision Date	01/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review