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510(k) K152769

FREMAP ELECTRODE by Ad-Tech Medical Instrument Corporation — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2016
Date Received
September 25, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

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