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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 K851141
Device Name TELEFLEX MEDICAL INTRODUCER CATHETER
Original Applicant
TELEFLEX MEDICAL, INC.
tall pines park
jaffrey,  NH  03452
Original Contact herbert m carter
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/21/1985
Decision Date 05/16/1985
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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