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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Materials, Repair Or Replacement, Pacemaker
510(k) Number K852236
Device Name MEDTRONIC MODEL 5867-1A
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Applicant Contact ED W NUMAINVILLE
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Correspondent Contact ED W NUMAINVILLE
Regulation Number870.3710
Classification Product Code
KFJ  
Date Received05/22/1985
Decision Date 07/11/1985
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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