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510(k) K861368

MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR by Medtronic Vascular — Product Code JOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1986
Date Received
April 11, 1986
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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