FDA 510(k) Application Details - K100029

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K100029
Device Name	Dressing, Wound, Drug
Applicant	MOLNLYCKE HEALTH CARE 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS, GA 30092 US Other 510(k) Applications for this Company
Contact	STEVEN DOWDLEY 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	01/06/2010
Decision Date	09/15/2010
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