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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 K181194
Device Name SmartMouth DryMouth Oral Rinse
Applicant
Triumph Pharmaceuticals, Inc.
12312 Olive Blvd., Suite 250
St. Louis,  MO  63141
Applicant Contact Andrew Burch
Correspondent
Wood Burditt Group
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact H. Carl Jenkins
Classification Product Code
LFD  
Date Received05/04/2018
Decision Date 02/15/2019
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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