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FDA 510(k) Applications Submitted by Liesbeth Decoster
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230951
04/04/2023
Terumo Injection Filter Needle (NF-3013RBKE05M)
Terumo Europe N.V.
K251447
05/09/2025
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
Terumo Europe N.V.
K243309
10/21/2024
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
Terumo Europe N.V.
K243581
11/14/2024
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
Terumo Europe N.V.
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