FDA 510(k) Application Details - K974084

Device Classification Name	Light, Surgical, Ceiling Mounted   More FDA Info for this Device
510(K) Number	K974084
Device Name	Light, Surgical, Ceiling Mounted
Applicant	GETINGE/CASTLE, INC. 7371 SPARTAN BLVD E. NORTH CHARLESTON, SC 29418 US Other 510(k) Applications for this Company
Contact	TREVOR WILLIAMSON 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	10/29/1997
Decision Date	03/03/1998
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