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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
510(k) Number K851091
Device Name MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440 -9087
Applicant Contact JOHNSON
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440 -9087
Correspondent Contact JOHNSON
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received03/18/1985
Decision Date 04/16/1985
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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