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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K923407
Device Name MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact JOHN M OTTO
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact JOHN M OTTO
Regulation Number870.3680
Classification Product Code
LDF  
Date Received07/10/1992
Decision Date 10/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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