FDA 510(k) Application Details - K043213

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K043213
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	KOWA CO. LTD. 1801 ROCKVILLE PIKE SUITE 300 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	RICHARD N PHILLIPS 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	11/19/2004
Decision Date	10/06/2005
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