FDA 510(k) Application Details - K083323

Device Classification Name	Light, Surgical, Ceiling Mounted   More FDA Info for this Device
510(K) Number	K083323
Device Name	Light, Surgical, Ceiling Mounted
Applicant	NUVO, INC. 5368 KUHL RD. ERIE, PA 16407 US Other 510(k) Applications for this Company
Contact	CURT V SCHAAFF 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	11/12/2008
Decision Date	01/28/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review