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FDA 510(k) Application Details - K123477
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1210
More FDA Info for this Regulation Number
Classification Product Code
KRA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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