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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 K201641
Device Name Disposable Laparoscope Trocar
Applicant
Beijing Biosis Healing Biological Technology Co., Ltd.
No.6 plant west, Valley No.1 Bio-medicine Industry Park
Daxing District
Beijing,  CN 102600
Applicant Contact Jiali Zhou
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 Received06/16/2020
Decision Date 08/06/2020
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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