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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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More FDA Info for this Product Code
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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