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FDA 510(k) Application Details - K082613
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K082613
Device Name
Catheter, Continuous Flush
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
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Contact
MICHAELA RIVKOWICH
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Regulation Number
870.1210
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Classification Product Code
KRA
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More FDA Info for this Product Code
Date Received
09/08/2008
Decision Date
12/30/2008
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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