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The effect of oral glucose on serum free insulin-like growth factor-I and -II in health adults

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Devices that are part of the Breakthrough Devices Program, have received FDA marketing authorization for the indication covered by the Breakthrough Devices designation, and meet the other criteria in the regulation can be approved through the quarterly process and announced through that process (81 FR 79655)

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The applicant asserted its belief that the study was appropriately designed and provides strong evidence that the use of disposable scopes is associated with reduced post-procedure encounters