FDA 510(k) Application Details - K082613

Device Classification Name Catheter, Continuous Flush

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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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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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