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510(k) K252632

Microwave Ablation Device by Nanjing Dewen Medical Technology Co., Ltd. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2026
Date Received
August 20, 2025
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

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