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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 K904475
Device Name ENTREE SHEATH INTRODUCER SYSTEM
Original Applicant
CORDIS CORP.
p.o. box 025700
miami,  FL  33102
Original Contact peggy r singer
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/01/1990
Decision Date 04/01/1991
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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