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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 K180208
Device Name Disposable Endoscopic Trocar
Applicant
Fengh Medical Co., Ltd.
D3 # 6 Dongsheng W. Rd.
Jiangyin National High-Tech Zone
Wuxi,  CN 214437
Applicant Contact Jun Zhou
Correspondent
Fengh Medical Co., Ltd.
D3 # 6 Dongsheng W. Rd.
Jiangyin National High-Tech Zone
Wuxi,  CN 214437
Correspondent Contact Jun Zhou
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/24/2018
Decision Date 04/09/2018
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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