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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 K232460
Device Name Disposable electrosurgical pencil (MD1000)
Applicant
Shenzhen Mecun Medical Supply Co., Ltd.
2nd Level, 2nd Bldg., Fuqiang S&T Park 6 Ailian
Industrial Park,Zhugushi,Wulian Community, Longgang District
Shenzhen,  CN 518000
Applicant Contact Bo Zheng
Correspondent
Shenzhen Mecun Medical Supply Co., Ltd.
2nd Level, 2nd Bldg., Fuqiang S&T Park 6 Ailian
Industrial Park,Zhugushi,Wulian Community, Longgang District
Shenzhen,  CN 518000
Correspondent Contact Bo Zheng
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/15/2023
Decision Date 10/11/2023
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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