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While products authorized through the De Novo pathway have no legally marketed predicate device, devices that are classified into class I or class II through a De Novo authorization may be marketed and used as predicates for future premarket notification (that is, 510(k)) submissions, when applicable

SLA-3000 rotor, Sorvall RC B5-Plus)

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However, you should consider taking it with the assistance of a healthcare provider if you believe that the side effects of this medication are worsening and you are worried about them

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