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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 K812599
Device Name MEDTRONIC #4951
Applicant
MEDTRONIC VASCULAR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDTRONIC VASCULAR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.3680
Classification Product Code
DTB  
Date Received09/14/1981
Decision Date 10/23/1981
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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