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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 K120178
Device Name WINGMAN EXTENDABLE TIP SUPPORT CATHETER
Original Applicant
REFLOW MEDICAL
1003 calle sombra
san clemente,  CA  92673
Original Contact rebecca k pine
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/20/2012
Decision Date 02/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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