FDA 510(k) Applications Submitted by Xiaolei Tian

FDA 510(k) Number Submission Date Device Name Applicant
K220057 01/06/2022 Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization Shinva Ande Healthcare Apparatus Co., Ltd.
K211484 05/12/2021 DisposableáSterileáSyringeáwitháSafetyáNeedle; DisposableáSterileáSyringeáwitháNeedle; DisposableáSterileáSyringe; DisposableáSafetyáNeedles Shinva Ande Healthcare Apparatus Co., Ltd.
K201460 06/02/2020 Closed System Transfer Device Shinva Ande Healthcare Apparatus Co., Ltd.
K162601 09/19/2016 Infusion Set for Single Use SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD.
K193657 12/30/2019 Disposable Enteral Feeding Syringe with Enfit Connector Shinva Ande Healthcare Apparatus Co., Ltd.


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