Name: Predicase
Price: 199 USD

K-number	K173237
Device name	Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
Applicant	Syendgen, Inc.
Product code	LFD
Device class	Class U
Decision date	Mar 19, 2018
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

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