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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, #2 & #3 Bldg.
38# N. Guandu Rd., Wuzhong District
Suzhou,  CN 215100
Applicant Contact Yu Zhu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. 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
Predetermined Change
Control Plan Authorized		 No
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