FDA 510(k) Application Details - K093520

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K093520
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	MICHELSON DIAGNOSTICS LTD. 11A GRAYS FARM PRODUCTION VILL GRAYS FARM ROAD ORPINGTON, KENT BR5 3BD GB Other 510(k) Applications for this Company
Contact	MARTIN JOHNS 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	11/13/2009
Decision Date	01/05/2010
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