FDA 510(k) Application Details - K063640

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K063640
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME CHUO-KU, TOKYO 103-8433 JP Other 510(k) Applications for this Company
Contact	SATOHIKO TAKANASHI 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	12/07/2006
Decision Date	12/18/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review