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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 K250390
Device Name CloSYS® Dry Mouth Sensitive Mouth Rinse
Applicant
Rowpar Pharmaceuticals, Inc.
440 Us Highway 22
Suite 210
Bridgewater,  NJ  08807
Applicant Contact Michael Tune
Correspondent
Innovative Science Solutions (D.B.A Lumanity)
10 N Park Place
Suite 201
Morristown,  NJ  07960
Correspondent Contact Steven Weisman
Classification Product Code
LFD  
Date Received02/11/2025
Decision Date 05/19/2025
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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