FDA 510(k) Application Details - K033869

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K033869
Device Name	Dressing, Wound, Drug
Applicant	COLOPLAST CORP. 1940 COMMERCE DR. NORTH MANKATO, MN 56003 US Other 510(k) Applications for this Company
Contact	ELIZABETH BOOTS 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	12/12/2003
Decision Date	05/17/2004
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