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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K010128
Device Name COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
Original Applicant
COOK VASCULAR, INC.
p.o. box 529
leechburg,  PA  15656
Original Contact thomas j kardos
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/16/2001
Decision Date 04/25/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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