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This is already the practice for some types of 510(k)s, which require clinical studies to document performance standards and will be further clarified through the finalization of draft guidance on Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions 18

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Balen: 90 kapsl (70,47 g) Dvkovn: Berte 1-3 kapsle prbn bhem dne, nebo podle doporuen lkae