FDA 510(k) Application Details - K121819

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K121819
Device Name	Dressing, Wound, Drug
Applicant	COVALON TECHNOLOGIES, INC. 405 BRITANNIA RD. EAST SUITE 106 MISSISSAUGA, ONTARIO L4Z 3E6 CA Other 510(k) Applications for this Company
Contact	CHRISTOPHER FREDRIC Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2012
Decision Date	08/13/2012
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