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FDA 510(k) Application Details - K122321
Device Classification Name
Syringe, Balloon Inflation
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510(K) Number
K122321
Device Name
Syringe, Balloon Inflation
Applicant
MERIT MEDICAL IRELAND, LTD.
1600 WEST MERIT PARKWAY
SOUTH JORDAN, UT 84095 US
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Contact
STEPHANIE ERSKINE
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Regulation Number
870.1650
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Classification Product Code
MAV
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More FDA Info for this Product Code
Date Received
08/01/2012
Decision Date
12/19/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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