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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 K874106
Device Name GLANDOSANE (SALIVART) SYNTHETIC SALIVA
Applicant
Fresenius USA, Inc.
Verwaltung: Borkenberg 14
6370 Oberursel/Taunus 1
Germany,  DE
Applicant Contact ERIC HOLST
Correspondent
Fresenius USA, Inc.
Verwaltung: Borkenberg 14
6370 Oberursel/Taunus 1
Germany,  DE
Correspondent Contact ERIC HOLST
Classification Product Code
LFD  
Date Received10/09/1987
Decision Date 04/15/1988
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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