FDA 510(k) Application Details - K974433

Device Classification Name	Light, Surgical, Ceiling Mounted   More FDA Info for this Device
510(K) Number	K974433
Device Name	Light, Surgical, Ceiling Mounted
Applicant	BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 TUTTLINGEN D-78532 DE Other 510(k) Applications for this Company
Contact	WOLFRAM K HILL 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	11/24/1997
Decision Date	02/20/1998
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