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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 K241022
Device Name Sterile single use tip cleaner (WK800-S10 , WK800-S20)
Applicant
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Tangjiao Xingwang St., Lilin Town, Zhongkai Hi-Tech Zone
Huizhou,  CN 516003
Applicant Contact Haobin Li
Correspondent
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Tangjiao Xingwang St., Lilin Town, Zhongkai Hi-Tech Zone
Huizhou,  CN 516003
Correspondent Contact Haobin Li
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/15/2024
Decision Date 07/11/2024
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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