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510(k) K232241

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) by Betters(Suzhou) Medical Co., Ltd. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2023
Date Received
July 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Betters(Suzhou) Medical Co., Ltd.

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