FDA 510(k) K182819, Decanting Device, by Gcmedica Enterprise Ltd.(Wuxi)

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510(K) Number: K182819 Device Name: Decanting Device Manufacturer: Gcmedica Enterprise Ltd.(Wuxi) Device Classification Name: Set, I.V. Fluid Transfer Regulation Number: LHI Classi fication Product Code: KXA Date Received: 10/04/2018 Decision Date: 12/02/2019 Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General Hospital Show more