FDA 510(k) Application Details - K182306

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K182306
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	Chongqing Sunkingdom Medical Instrument Co Ltd 1012, Block A of China Resource Center No.55 of XieJiaWan,JiuLongPo Chongqing 400050 CN Other 510(k) Applications for this Company
Contact	Joy Tse 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	08/24/2018
Decision Date	11/22/2018
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