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510(k) K851091

MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR by Medtronic Vascular — Product Code JOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1985
Date Received
March 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Device Class
Class II
Regulation Number
870.1750
Review Panel
CV
Submission Type

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