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FDA 510(k) Applications Submitted by Susan Sun
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221507
05/23/2022
Disposable Blood Lancet
SteriLance Medical (Suzhou) Inc.
K221521
05/25/2022
Disposable Safety Lancet
SteriLance Medical (Suzhou) Inc.
K221970
07/05/2022
Lancing device
SteriLance Medical(Suzhou) Inc.
K233796
11/29/2023
Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
SteriLance Medical (Suzhou) Inc.
K244031
12/30/2024
Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
SteriLance Medical (Suzhou) Inc.
K244036
12/30/2024
Heel Incision Safety Lancet (SteriHeel 2)
SteriLance Medical (Suzhou) Inc.
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