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FDA 510(k) Applications Submitted by Freddie Lee
FDA 510(k) Number
Submission Date
Device Name
Applicant
K240171
01/22/2024
ProSealÖ Injector Plus (Model no. 421050)
Epic Medical Pte. Ltd.
K230343
02/08/2023
ProSealÖ Closed System Administration Set
Epic Medical Pte Ltd
K240433
02/14/2024
ProSealÖ Injection Site Extended Male Luer Lock (422140)
Epic Medical Pte. Ltd.
K240517
02/23/2024
ProSealÖ Vented Universal Vial Adaptor
Epic Medical Pte. Ltd.
K251340
04/30/2025
ProSealÖ Bag Spike with Additive Port (423370ST, 423370)
Epic Medical Pte. Ltd.
K241442
05/22/2024
eZSUREÖ Empty Fluid Container with ProSealÖ Injection Site
Epic Medical Pte. Ltd.
K241476
05/24/2024
ToxiSealÖ Vial Adaptor with External Flip Balloon
Epic Medical Pte. Ltd.
K201626
06/16/2020
Safety Subcutaneous Infusion Set
Epic Medical Pte. Ltd.
K241735
06/17/2024
ProSealÖ In Line Pump Set (423850)
Epic Medical Pte. Ltd.
K151650
06/18/2015
SMARTez elastomeric infusion pump
Epic Medical Pte Ltd
K241823
06/24/2024
ToxiSealÖ Vial Adaptor
Epic Medical Pte. Ltd.
K241988
07/08/2024
ProSealÖ Closed System Bag Access
Epic Medical Pte. Ltd.
K242152
07/23/2024
SMARTeZÖ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
Epic Medical Pte. Ltd.
K192075
08/02/2019
ProSealÖ Closed System drug Transfer Device (CSTD)
Epic Medical Pte. Ltd.
K222929
09/26/2022
ToxiSeal Vial Adapter with External Balloon
Epic Medical Pte Ltd
K223674
12/07/2022
eZSUREÖ Empty Fluid Container (models 426030, 426040, 426110)
Epic Medical Pte Ltd
K243976
12/23/2024
ZeroClearÖ Bag Access (423100)
Epic Medical Pte. Ltd.
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