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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K880323
Device Name MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
Applicant
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Applicant Contact SHARON D KVISTAD
Correspondent
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Correspondent Contact SHARON D KVISTAD
Regulation Number870.2900
Classification Product Code
DSA  
Date Received01/26/1988
Decision Date 03/22/1988
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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