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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 K812725
Device Name MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD
Applicant
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3680
Classification Product Code
LDF  
Date Received09/28/1981
Decision Date 11/16/1981
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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