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510(k) K221199

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) by Green Island International Tcm Group Limited — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2023
Date Received
April 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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