FDA 510(k) Application Details - K102758

Device Classification Name	Light, Surgical, Ceiling Mounted   More FDA Info for this Device
510(K) Number	K102758
Device Name	Light, Surgical, Ceiling Mounted
Applicant	TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG 1046 LEGRAND BOULEVARD CHARLESTON, SC 29492 US Other 510(k) Applications for this Company
Contact	LINDSEY RONNENBERG Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2010
Decision Date	10/26/2010
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	Y
Expedited Review