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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 K123731
FOIA Releasable 510(k) K123731
Device Name BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
Applicant
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
1500 LITTLETON ROAD
PARSIPPANY,  NJ  07054
Applicant Contact PAUL KRUMM
Correspondent
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
1500 LITTLETON ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact PAUL KRUMM
Classification Product Code
LFD  
Date Received12/05/2012
Decision Date 01/04/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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