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510(k) K141076

GARMENT ELECTRODES by Shenzhen Dongdixin Technology Co., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2014
Date Received
April 25, 2014
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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