FDA 510(k) Application Details - K060224

Device Classification Name Catheter, Continuous Flush

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510(K) Number K060224
Device Name Catheter, Continuous Flush
Applicant COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 US
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Contact THALIA BRINE
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 01/30/2006
Decision Date 03/06/2006
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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