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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 K001985
Device Name INTRODEUCE DOUBLE LUMEN INTRODUCER
Original Applicant
COOK, INC.
p.o. box 489
bloomington,  IN  47402
Original Contact april lavender
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/29/2000
Decision Date 01/25/2001
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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