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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K233140
Device Name Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
Applicant
Hygea Medical Technology Co., Ltd.
Floor 6&7, W. Area Of Bldg. # 8, #30 Yuhua
Rd., Shunyi
Beijing,  CN 101318
Applicant Contact Jinping Duan
Correspondent
Hygea Medical Technology Co., Ltd.
Floor 6&7, W. Area Of Bldg. # 8, #30 Yuhua
Rd., Shunyi
Beijing,  CN 101318
Correspondent Contact Jinping Duan
Regulation Number878.4400
Classification Product Code
NEY  
Date Received09/27/2023
Decision Date 01/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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