Name: Predicase
Price: 199 USD

K-number	K171542
Device name	TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
Applicant	Dr. Harold Katz, LLC (Dba Therabreath
Product code	LFD
Device class	Class U
Decision date	Mar 16, 2018
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges

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