FDA 510(k) Application Details - K153690

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K153690
Device Name	Dressing, Wound, Collagen
Applicant	TEI BioSciences Inc. 7 Elkins Street Boston, MD 02127 US Other 510(k) Applications for this Company
Contact	David D Cox 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	12/23/2015
Decision Date	02/22/2016
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