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510(k) K200088

g.Estim FES by G.Tec Medical Engineering GmbH — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2020
Date Received
January 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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