FDA 510(k) Application Details - K100884

Device Classification Name	Lamp, Surgical   More FDA Info for this Device
510(K) Number	K100884
Device Name	Lamp, Surgical
Applicant	HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 US Other 510(k) Applications for this Company
Contact	AVITAL MERL-MARGULIES 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	03/30/2010
Decision Date	06/25/2010
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