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ELLAVI UBT — Sinapi Biomedical (Pty) , Ltd. (510(k) K230849)

ELLAVI UBT — Sinapi Biomedical (Pty) , Ltd. (510(k) K230849) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ELLAVI UBT; Applicant: Sinapi Biomedical (Pty) , Ltd.; Clearance track: 510(k).

Device nameELLAVI UBT
ApplicantSinapi Biomedical (Pty) , Ltd.
Clearance track510(k)
Submission numberK230849
DecisionSubstantially Equivalent
Decision date2023-11-13
Date received2023-03-28
Product codeOQY
Device class2
Medical specialtyObstetrics/Gynecology
Applicant locationZA
SourceopenFDA device

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