FDA 510(k) Application Details - K131589

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K131589
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	KEELER LTD. CLEWER HILL RD. WINDSOR, BERKSHIRE SL4 4AA GB Other 510(k) Applications for this Company
Contact	NICKIE POWER 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	05/31/2013
Decision Date	06/27/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review