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1. Full Breath Sleep Appliance Lower- This appliance is indicated for the treatment of snoring.
2. Full Breath Sleep Appliance Lower This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.

The Full Breath Soution Lower is a custom fabricated device which is typically done by a professional dental laboratory and delivered by a dentist.

There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA letter for a PREDICATE DEVICE COMPARISON TABLE:
dental appliance, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against specific acceptance criteria.

The document indicates that "All the research and data gathered for 510(k) K061228 are applicable for this application for certification," referring to a previously cleared device. However, the details of that prior research and data, including acceptance criteria and study particulars, are not included in the provided text.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study that proves the device meets them based on the given information.

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