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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 K103745
Device Name BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
Applicant
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
1500 LITTLETON ROAD
PARSIPPANY,  NJ  07054
Applicant Contact WENDY A MCMANUS
Correspondent
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
1500 LITTLETON ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact WENDY A MCMANUS
Classification Product Code
LFD  
Date Received12/23/2010
Decision Date 07/20/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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