FDA 510(k) Application Details - K103106

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K103106
Device Name	Dressing, Wound, Drug
Applicant	CARE FUSION 213 LLC 11400 TOMAHAWK CREEK PARKWAY SUITE 310 LEAWOOD, KS 66211 US Other 510(k) Applications for this Company
Contact	ARLEN JOHNSON 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	10/20/2010
Decision Date	03/30/2011
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