K-number	K181396
Device name	Oral Device OA, Oral Device S
Applicant	Passion For Life Healthcare (Uk) Limited
Product code	LRK
Device class	Class II
Decision date	Nov 16, 2018
Decision	Substantially Equivalent
Regulation	872.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Oral Device OA, Oral Device S

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