FDA 510(k) Application Details - K070287

Device Classification Name	Light, Surgical Headlight   More FDA Info for this Device
510(K) Number	K070287
Device Name	Light, Surgical Headlight
Applicant	PHOTONIC OPTISCHE GERATE GMBH & COKG SEEBOCKGASSE 59 VIENNA A-1160 AT Other 510(k) Applications for this Company
Contact	DIETER FEGER Other 510(k) Applications for this Contact
Regulation Number	872.4630   More FDA Info for this Regulation Number
Classification Product Code	EBA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2007
Decision Date	02/12/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review