FDA 510(k) Application Details - K093386

Device Classification Name	Light, Surgical, Fiberoptic   More FDA Info for this Device
510(K) Number	K093386
Device Name	Light, Surgical, Fiberoptic
Applicant	BFW, INC 2307 RIVER ROAD SUITE 103 LOUISVILLE, KY 40206 US Other 510(k) Applications for this Company
Contact	LYNN COOPER Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2009
Decision Date	01/28/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review