FDA 510(k) Application Details - K093857

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K093857
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	LIGHTLAB IMAGING,INC. 7 TRAIL HOUSE CT ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	CHRISTINE BRAUER 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	12/16/2009
Decision Date	04/30/2010
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