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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 K895044
Device Name DUAL GUIDE INTRODUCER CATHETER
Original Applicant
COOK, INC.
925 south curry pike
p.o. box 489
bloomington,  IN  47402
Original Contact april lavender
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/09/1989
Decision Date 02/26/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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