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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
Applicant
MERIT MEDICAL IRELAND, LTD.
1600 WEST MERIT PARKWAY
SOUTH JORDAN,  UT  84095
Applicant Contact STEPHANIE ERSKINE
Correspondent
MERIT MEDICAL IRELAND, LTD.
1600 WEST MERIT PARKWAY
SOUTH JORDAN,  UT  84095
Correspondent Contact STEPHANIE ERSKINE
Regulation Number870.1650
Classification Product Code
MAV  
Date Received08/01/2012
Decision Date 12/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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