FDA 510(k) Application Details - K100218

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K100218
Device Name	Dressing, Wound, Drug
Applicant	COLOPLAST A/S 1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	REBEKA STOLTMAN 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	01/26/2010
Decision Date	02/17/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review