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FDA 510(k) Applications Submitted by Shinva Ande Healthcare Apparatus Co., Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K202060
07/27/2020
Disposable IV catheter
Shinva Ande Healthcare Apparatus Co., Ltd.
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.
K193657
12/30/2019
Disposable Enteral Feeding Syringe with Enfit Connector
Shinva Ande Healthcare Apparatus Co., Ltd.
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