FDA 510(k) Application Details - K083440

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K083440
Device Name	Dressing, Wound, Collagen
Applicant	TEI BIOSCIENCES INC. 7 ELKINS ST. BOSTON, MA 02127 US Other 510(k) Applications for this Company
Contact	KENNETH JAMES 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	11/20/2008
Decision Date	12/12/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review