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Zdrowie i gospodarka · 18/09/2014

FDA Proposes Reclassification of Salivary Stimulatory System as Electrical Salivary Stimulator System

The US Food and Drug Administration (FDA) is proposing to reclassify the salivary stimulatory system, a Class III medical device, into Class II, subject to premarket notification, and rename it the electrical salivary stimulator system, which is believed to provide a reasonable assurance of safety and effectiveness.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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