K-number	K181194
Device name	SmartMouth DryMouth Oral Rinse
Applicant	Triumph Pharmaceuticals, Inc.
Product code	LFD
Device class	Class U
Decision date	Feb 15, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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SmartMouth DryMouth Oral Rinse

Everything you need for a 510(k) submission. Nothing you don't.