FDA 510(k) Application Details - K033783

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K033783
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	IMALUX COPORATION 1771 EAST 30TH ST. CLEVELAND, OH 44114 US Other 510(k) Applications for this Company
Contact	STEPHANIE A.S. HARRINGTON Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	NQQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2003
Decision Date	03/01/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review