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FDA 510(k) Application Details - K123369
Device Classification Name
System, Imaging, Optical Coherence Tomography (Oct)
More FDA Info for this Device
510(K) Number
K123369
Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Applicant
LIGHTLAB IMAGING, INC.
4 ROBBINS ROAD
WESTFORD, MA 01886 US
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Contact
JEFFREY ROBERTS
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
NQQ
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More FDA Info for this Product Code
Date Received
11/01/2012
Decision Date
01/30/2013
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
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