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Most LDTs are expected to require a 510(k) or de novo , but if the type of submission is unknown, the regulatory pathway/strategy should first be determined

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[DOI] [Google Scholar] 224.Nawarathne N.W., Wijesekera K., Wijayaratne W.M.D.G.B., Napagoda M

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Typically, it takes a few treatment sessions to see results, although it depends on each person

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