FDA 510(k) Application Details - K152429

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K152429
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. Zone A, 2nd Floor, No. 69, Lane 1985, Chunshen Road Minhang District, SHANGHAI 200237 CN Other 510(k) Applications for this Company
Contact	WEIDA ZHAN 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	08/26/2015
Decision Date	05/11/2016
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