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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 K003729
Device Name ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),
Applicant
St Jude Medical
14901 De Veau Place
Minnetonka,  MN  55345
Applicant Contact ANGELA BYLAND
Correspondent
St Jude Medical
14901 De Veau Place
Minnetonka,  MN  55345
Correspondent Contact ANGELA BYLAND
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/04/2000
Decision Date 01/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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