FDA 510(k) Application Details - K961668

Device Classification Name Catheter, Continuous Flush

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510(K) Number K961668
Device Name Catheter, Continuous Flush
Applicant COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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Contact APRIL LAVENDER
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 04/30/1996
Decision Date 11/04/1996
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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