FDA 510(k) Application Details - K100234

Device Classification Name	Lamp, Surgical   More FDA Info for this Device
510(K) Number	K100234
Device Name	Lamp, Surgical
Applicant	HILLUSA, INC. 7215 N.W. 46TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	MARIA GUMA Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2010
Decision Date	07/08/2010
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