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510(k) K180232

DAEHAN Disposable CUP Electrodes by Daehan Medical Systems Co., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2019
Date Received
January 29, 2018
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

Other clearances by Daehan Medical Systems Co., Ltd.

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