FDA 510(k) Application Details - K033190

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K033190
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	SUZHOU 66 VISION-TECH CO., LTD 6833 SAINT LAWRENCE STREET PLANO, TX 75024 US Other 510(k) Applications for this Company
Contact	ERIC LUO 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	10/01/2003
Decision Date	12/04/2003
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