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510(k) K173815

Allergan Botox Needle Electrode by Natus Manufacturing Limited — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2018
Date Received
December 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

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