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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
Device Name MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
Applicant
MOOR INSTRUMENTS LTD.
MILLWEY
AXMINSTER, DEVON,  GB EX135HU
Applicant Contact STEWART LILLINGTON
Correspondent
MOOR INSTRUMENTS LTD.
MILLWEY
AXMINSTER, DEVON,  GB EX135HU
Correspondent Contact STEWART LILLINGTON
Regulation Number870.2120
Classification Product Code
DPT  
Date Received09/24/2012
Decision Date 01/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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