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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 K233263
Device Name Disposable Trocars
Applicant
Hangzhou Kangji Medical Instrument Co., Ltd.
No. 1668 Chunjiang East Road, Economic Development Zone
Tonglu
Hangzhou,  CN 311501
Applicant Contact Martin Sun
Correspondent
Shanghai Ling Fu Technology Co., Ltd.
4F No. 585-2, Wanyuan Rd. Minhang District
Shanghai,  CN 201102
Correspondent Contact Esther Zhang
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/29/2023
Decision Date 04/09/2024
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
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