FDA 510(k) Application Details - K080868

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K080868
Device Name	Dressing, Wound, Collagen
Applicant	AEON ASTRON EUROPE B.V. NIELS BOHRWEG 11-13 LEIDEN 2333 NL Other 510(k) Applications for this Company
Contact	HORNG J LAI 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	03/28/2008
Decision Date	05/14/2009
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