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Measurement (U-100): At 1.67 mg/mL , 1 unit (0.01 mL) 16.7 mcg

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The applicant further summarized evidence included in its application to support its assertion that the aprevo Cervical ACDF System is substantively distinct and significantly different from the expired device category C1831

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The duration of B12 supplementation depends on individual needs, lifestyle, and lab results