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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 K201262
Device Name Microwave Therapeutic System
Applicant
Nanjing Eco Microwave System Co., Ltd.
Third & Fourth Floors, J5 Bldg., # 15 Wanshou Rd.,
Pukou District
Nanjing,  CN 211800
Applicant Contact Hong Wei
Correspondent
Nanjing Eco Microwave System Co., Ltd.
Third & Fourth Floors, J5 Bldg., # 15 Wanshou Rd.,
Pukou District
Nanjing,  CN 211800
Correspondent Contact Hong Wei
Regulation Number878.4400
Classification Product Code
NEY  
Date Received05/11/2020
Decision Date 07/09/2021
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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