FDA 510(k) Application Details - K140461

Device Classification Name	Light, Surgical, Ceiling Mounted   More FDA Info for this Device
510(K) Number	K140461
Device Name	Light, Surgical, Ceiling Mounted
Applicant	DR. MACH GMBH & CO. KG FEHMARNSTRASSE 31 NORDERSTEDT, SCHLESWIG-HOLSTEIN 22846 DE Other 510(k) Applications for this Company
Contact	GUDRUN BUSCH, PH.D. 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	02/24/2014
Decision Date	04/03/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review