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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 K231042
Device Name Disposable Laparoscopic Trocar
Applicant
Changzhou Ankang Medical Instruments Co., Ltd.
A4 Standard Workshop, Hutang Science And Technology
Industrial Park, Hutang Town, Wujin District
Changzhou,  CN 213162
Applicant Contact Tingting Cao
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/12/2023
Decision Date 06/08/2023
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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