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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 K140327
Device Name ULTIMUM EV HEMOSTASIS INTRODUCER
Applicant
ST. JUDE MEDICAL
5050 NATHAN LANE N
PLYMOUTH,  MN  55442
Applicant Contact LOUCINDA BJORKLUND
Correspondent
ST. JUDE MEDICAL
5050 NATHAN LANE N
PLYMOUTH,  MN  55442
Correspondent Contact LOUCINDA BJORKLUND
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/10/2014
Decision Date 03/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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