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510(k) K053214

THERAKNIT GARMENT ELECTRODE by Neurotron Medical — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2005
Date Received
November 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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