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510(k) K950425

TECOTHANE 55D by Medtronic Vascular — Product Code GZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1995
Date Received
February 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5870
Review Panel
NE
Submission Type

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