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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 K031906
Device Name APEEL CS CATHETER DELIVERY SYSTEM
Applicant
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA,  MN  55345 -2126
Applicant Contact MIKE BURNSIDE
Correspondent
ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA,  MN  55345 -2126
Correspondent Contact MIKE BURNSIDE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/20/2003
Decision Date 07/18/2003
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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