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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 K142657
Device Name XEROSTOM SALIVA SUBSTITUTE GEL
Applicant
Bio Cosmetics, S.L.
Calle Araquil, 11
Madrid,  ES 28023
Applicant Contact SUSANA SARDON
Correspondent
Liberty Management Group , Ltd.
2871 Coastal Dr.
Aurora,  IL  60503
Correspondent Contact MANOJ ZACHARIAS
Classification Product Code
LFD  
Date Received09/18/2014
Decision Date 09/14/2015
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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