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510(k) K140200

E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES by Neuroinvent, Inc. — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2014
Date Received
January 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

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