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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 K885101
Device Name MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Applicant Contact D KVISTAD
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Correspondent Contact D KVISTAD
Regulation Number870.2900
Classification Product Code
DSA  
Date Received12/12/1988
Decision Date 01/12/1989
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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