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510(k) K232581

Medical Disposable Sterile Needle Electrode by Suzhou Haishen Medical Device Associates Co., Ltd. — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2023
Date Received
August 25, 2023
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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