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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name probe, blood-flow, extravascular
510(K) Number K122943
Model MOORFLPI-2
Device Name MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
Applicant
MOOR INSTRUMENTS LTD.
millwey
axminster, devon, 
Contact stewart lillington
Regulation Number870.2120
Classification Product Code
DPT  
Date Received09/24/2012
Decision Date 01/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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