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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K171542
Device Name TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
Applicant
Dr. Harold Katz, LLC (dba TheraBreath
5802 Willoughby Avenue
Los Angeles,  CA  90038
Applicant Contact Harold Katz
Correspondent
Clinical Research Consultants, Inc.
3308 Jefferson Avenue, Upper Level
Cincinnati,  OH  45220
Correspondent Contact Barbara S. Fant
Classification Product Code
LFD  
Date Received05/26/2017
Decision Date 03/16/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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