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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K222828
Device Name Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
Applicant
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Tangjiao Xingwang St., Lilin Town, Zhongkai Hi-Tech Zone
Huizhou,  CN 516003
Applicant Contact Mac Lai
Correspondent
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Tangjiao Xingwang St., Lilin Town, Zhongkai Hi-Tech Zone
Huizhou,  CN 516003
Correspondent Contact Mac Lai
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/19/2022
Decision Date 03/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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