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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K912084
Device Name MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
Applicant
Medtronic Vascular
P.O. Box 1453
Minneapolis,  MN  55440
Applicant Contact JACQUES P SCHWARTZ
Correspondent
Medtronic Vascular
P.O. Box 1453
Minneapolis,  MN  55440
Correspondent Contact JACQUES P SCHWARTZ
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/13/1991
Decision Date 07/30/1991
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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