FDA 510(k) Application Details - K063148

Device Classification Name	Oral Wound Dressing   More FDA Info for this Device
510(K) Number	K063148
Device Name	Oral Wound Dressing
Applicant	MERLIN GROUP DBA MCMERLIN DENTAL COMPANY 1610 W. POLO RD SUITE A GRAND PRAIRIE, TX 75052 US Other 510(k) Applications for this Company
Contact	EILEEN VENNUM 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	10/16/2006
Decision Date	01/17/2007
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