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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 K183564
Device Name Electrosurgical Generator
Applicant
Fulwell LLC
3411 NW 48 Street
Miami,  FL  33142
Applicant Contact Xi Chen
Correspondent
Guangzhou KEDA Testing Tech Co., Ltd.
6F, No.1 TianTai road, Science City, LuoGang District
GuangZhou,  CN 510060
Correspondent Contact Jet Li
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/20/2018
Decision Date 06/13/2019
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
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