FDA 510(k) Application Details - K063352

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K063352
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	TAKAGI SEIKO CO., LTD. 82 GILBERT STREET ADELAIDE, SOUTH AUSTRALIA 5000 AU Other 510(k) Applications for this Company
Contact	KEVIN HOWARD Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	HJO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2006
Decision Date	03/13/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review