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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 K861368
Device Name MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Applicant Contact TIMOTHY J JOHNSON
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Correspondent Contact TIMOTHY J JOHNSON
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received04/11/1986
Decision Date 08/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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