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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 K232866
Device Name Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
Applicant
Jiangsu Channel Medical Device Co., Ltd.
Fourth Floor, G3,999# Qujia Rd., Qiandeng Town
Kushan,  CN 215341
Applicant Contact Eric Huang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/15/2023
Decision Date 11/07/2023
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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