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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 K894981
Device Name MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE
Applicant
Medtronic Vascular
60 Newark St.
Haverhill,  MA  01830
Applicant Contact JANICE M PEVIDE
Correspondent
Medtronic Vascular
60 Newark St.
Haverhill,  MA  01830
Correspondent Contact JANICE M PEVIDE
Regulation Number870.2900
Classification Product Code
DSA  
Date Received08/08/1989
Decision Date 09/20/1989
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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