FDA 510(k) Application Details - K100439

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K100439
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. 1485 ANDREW DR SUITE G CLAREMONT, CA 91711 US Other 510(k) Applications for this Company
Contact	LISA ZHANG 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	02/17/2010
Decision Date	07/16/2010
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