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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 K051812
Device Name TGO SPRAY
Applicant
LABORATOIRES CARILENE S.A.S.
1800 MASSACHUSETTS AVE., NW
WASHINGTON,  DC  20036
Applicant Contact EMALEE MURPHY
Correspondent
LABORATOIRES CARILENE S.A.S.
1800 MASSACHUSETTS AVE., NW
WASHINGTON,  DC  20036
Correspondent Contact EMALEE MURPHY
Classification Product Code
LFD  
Date Received07/05/2005
Decision Date 10/21/2005
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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