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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, balloon inflation
510(k) Number K122321
Device Name BASIXCONPAK ANALOG INFLATION SYRINGE
Original Applicant
MERIT MEDICAL IRELAND, LTD.
1600 west merit parkway
south jordan,  UT  84095
Original Contact stephanie erskine
Regulation Number870.1650
Classification Product Code
MAV  
Date Received08/01/2012
Decision Date 12/19/2012
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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