FDA 510(k) Application Details - K112568

Device Classification Name	Oral Wound Dressing   More FDA Info for this Device
510(K) Number	K112568
Device Name	Oral Wound Dressing
Applicant	AEON ASTRON EUROPE B.V. NIELS BOHRWEG 11-13 LEIDEN 2333 CA NL Other 510(k) Applications for this Company
Contact	HORNG JI LAI Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2011
Decision Date	03/01/2012
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