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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K240975
Device Name Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)
Applicant
Beijing Taktvoll Technology Co., Ltd.
302 Rm., 10a, Lian Dong U Village, Jing Sheng Nan Fourth St.
Jin Qiao Chan Ye Ji Di, Tong Zhou District
Beijing,  CN 101102
Applicant Contact Fan Dan
Correspondent
Beijing Taktvoll Technology Co., Ltd.
302 Rm., 10a, Lian Dong U Village, Jing Sheng Nan Fourth St.
Jin Qiao Chan Ye Ji Di, Tong Zhou District
Beijing,  CN 101102
Correspondent Contact Fan Dan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/10/2024
Decision Date 12/23/2024
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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