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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
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