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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K122684
Model MIC-021-150
Device Name REVERSE MEDICAL MICROCATHETER
Original Applicant
REVERSE MEDICAL CORPORATION
13700 alton parkway suite 167
irvine,  CA  92618
Original Contact jeffrey valko
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received08/31/2012
Decision Date 12/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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