K-numberK233796
Device nameDisposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
ApplicantSteriLance Medical (Suzhou), Inc.
Product codeFMK
Device classClass II
Decision dateJan 16, 2024
DecisionSubstantially Equivalent
Regulation878.4850
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