FDA 510(k) Application Details - K100591

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K100591
Device Name	Dressing, Wound, Drug
Applicant	ABIGO MEDICAL AB 435 RICE CREEK TERRACE NE, FRIDLEY, MN 55432 US Other 510(k) Applications for this Company
Contact	CONSTANCE BUNDY 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	03/02/2010
Decision Date	01/24/2011
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