FDA 510(k) Application Details - K153545

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K153545
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. NO.29, Jiuyuan Road, Qingpu Industrial Park, Shanghai, Shanghai 201700 CN Other 510(k) Applications for this Company
Contact	Johnny Hu 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	12/11/2015
Decision Date	06/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review