FDA 510(k) Application Details - K080460

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K080460
Device Name	Tomography, Optical Coherence
Applicant	OPKO HEALTH, INC. 4400 BISCAYNE BLVD. MIAMI, FL 33137 US Other 510(k) Applications for this Company
Contact	JANE HSIAO 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	02/20/2008
Decision Date	11/14/2008
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