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510(k) Data Aggregation
K Number
K981923Device Name
THE SNORE PEACE
Manufacturer
Date Cleared
1998-08-24
(84 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
THE SNORE PEACE GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To reduce or alleviate snoring by holding the tongue and lower jaw in a 60-75% of patient maximum protrusion forward position during sleep.
Device Description
The Snore Peace® is a single piece device which is form custom fitted to the users upper and lower teeth and inner lips. It is meant to be worn at night while sleeping.
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