FDA 510(k) Applications Submitted by Yu Zhu

FDA 510(k) Number Submission Date Device Name Applicant
K212284 07/21/2021 Disposable Automatic Core Biopsy Instrument Suzhou Leapmed Healthcare Corporation
K212819 09/03/2021 Disposable Biopsy Refill Needle Suzhou Leapmed Healthcare Corporation
K212820 09/03/2021 Disposable Semi Automatic Biopsy Instrument Suzhou Leapmed Healthcare Corporation
K212822 09/03/2021 Disposable Coaxial Biopsy Needle Suzhou Leapmed Healthcare Corporation
K250946 03/28/2025 Denture Base Resin DT20 Hangzhou SHINING3D Dental Technology Co., Ltd.
K212385 08/02/2021 YUWELL Finger Pulse Oximeter Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
K203583 12/08/2020 YUWELL infrared ear thermometer: YHT101, YHT200 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd


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