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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 K920908
Device Name OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1
Applicant
Teleflex Medical, Inc.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact JO RUDZIENSKY
Correspondent
Teleflex Medical, Inc.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact JO RUDZIENSKY
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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