FDA 510(k) Application Details - K123477

Device Classification Name Catheter, Continuous Flush

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510(K) Number K123477
Device Name Catheter, Continuous Flush
Applicant SEQUENT MEDICAL, INC
11A COLUMBIA
ALISO VIEJO, CA 92656 US
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Contact MELANIE PARRAVI
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 11/13/2012
Decision Date 03/19/2013
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

FDA Source Information for K123477


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