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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 K162167
Device Name Caphosol Artifical Saliva Tablets
EUSA Pharma (UK) Limited
Breakspear Park, Breakspear Way
Hemel Hempstead,  GB HP2-4TZ
Applicant Contact Paul Davisson
Delphi Consulting Group
11874 South Evelyn Circle
Houston,  TX  77071 -3404
Correspondent Contact J. Harvey Knauss
Classification Product Code
Date Received08/03/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No