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FDA 510(k) Application Details - K052841
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K052841
Device Name
Catheter, Continuous Flush
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402 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
10/07/2005
Decision Date
12/08/2005
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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