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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 K232241
Device Name Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
Applicant
Betters(Suzhou) Medical Co., Ltd.
Rm. 101, 201, 501, Bldg. 7,52 Yin Gang Rd.
Taicang Port Economic And Technological Development Zone
Suzhou,  CN 215412
Applicant Contact Lei Liu
Correspondent
Aplus Healthcare Technology (Shanghai) Co., Ltd.
Rm. 223, Bldg. 17, Jy-Wisdombay
Huqing Rd. 158, Baoshan District
Shanghai,  CN
Correspondent Contact Ada Wang
Regulation Number878.4400
Classification Product Code
NEY  
Date Received07/28/2023
Decision Date 11/13/2023
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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