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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 K944956
Device Name UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
Applicant
The Heart Valve Div. Medtronic Cardiovascular Surg
7000 Central Ave., NE
P.O. Box 1350
Minneapolis,  MN  55440
Applicant Contact DIANA SALDITT
Correspondent
The Heart Valve Div. Medtronic Cardiovascular Surg
7000 Central Ave., NE
P.O. Box 1350
Minneapolis,  MN  55440
Correspondent Contact DIANA SALDITT
Regulation Number870.3680
Classification Product Code
LDF  
Date Received10/07/1994
Decision Date 07/14/1995
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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