FDA 510(k) Application Details - K063388

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K063388
Device Name	Tomography, Optical Coherence
Applicant	TOPCON CORP. 555 THIRTEENTH STREET NW COLUMBIA SQUARE WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHAN Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	OBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2006
Decision Date	06/22/2007
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