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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K843706
Device Name MEDTRONIC 6957
Applicant
Medtronic Vascular
P.O. Box 1453
Minneapolis,  MN  55440
Applicant Contact EDWARD W NUMAINVILL
Correspondent
Medtronic Vascular
P.O. Box 1453
Minneapolis,  MN  55440
Correspondent Contact EDWARD W NUMAINVILL
Regulation Number870.3680
Classification Product Code
DTB  
Date Received09/21/1984
Decision Date 12/27/1984
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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