FDA 510(k) Application Details - K080497

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K080497
Device Name	Dressing, Wound, Drug
Applicant	DERMA SCIENCES CANADA, INC. 104 SHORTING RD. TORONTO, ONTARIO M1S 3S4 CA Other 510(k) Applications for this Company
Contact	SHARMINI ATHERAY 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	02/22/2008
Decision Date	06/27/2008
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