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FDA 510(k) Application Details - K060224
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
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
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
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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