FDA 510(k) Application Details - K000368

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K000368
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	CLEMENT CLARKE INTL., LTD. EDINBURGH WAY HARLOW CM20 2TT GB Other 510(k) Applications for this Company
Contact	M.J. WILKINSON Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2000
Decision Date	05/04/2000
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