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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 K920907
Device Name OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO
Original Applicant
Teleflex Medical, Inc.
tall pines park
jaffrey,  NH  03452
Original Contact jo rudzidensky
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/27/1992
Decision Date 10/06/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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