FDA 510(k) Application Details - K131711

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K131711
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	SUZHOU 66 VISION TECH CO., LTD. NO. 34 DARU LANE SUZHOU, JIANGSU 215005 CN Other 510(k) Applications for this Company
Contact	HONGLING XIA 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	06/11/2013
Decision Date	05/09/2014
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