FDA 510(k) Application Details - K052738

Device Classification Name Catheter, Continuous Flush

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510(K) Number K052738
Device Name Catheter, Continuous Flush
Applicant VEINRX INC.
8200 N.W. 27TH ST., STE. 102
MIAMI, FL 33122 US
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Contact GREGORY J MATHISON
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 09/30/2005
Decision Date 12/06/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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