FDA 510(k) Application Details - K031629

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K031629
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042-1198 US Other 510(k) Applications for this Company
Contact	SHEILA DRISCOLL 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	05/27/2003
Decision Date	06/06/2003
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	Y
Expedited Review