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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
Applicant
Eusa Pharma (Uk) Limited
Breakspear Park, Breakspear Way
Hemel Hempstead,  GB HP2-4TZ
Applicant Contact Paul Davisson
Correspondent
Delphi Consulting Group
11874 S. Evelyn Cir.
Houston,  TX  77071
Correspondent Contact J. Harvey Knauss
Classification Product Code
LFD  
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
Predetermined Change
Control Plan Authorized		 No
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