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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name biopsy needle
510(k) Number K212822
Device Name Disposable Coaxial Biopsy Needle
Applicant
Suzhou Leapmed Healthcare Corporation
Wuzhong Science Park, NO.2 & NO.3 Building
38# North Guandu Road, Wuzhong District
Suzhou,  CN 215100
Applicant Contact Yu Zhu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.1801 ,No.161, East Lujiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/03/2021
Decision Date 07/06/2022
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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