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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 K101477
FOIA Releasable 510(k) K101477
Device Name BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
Applicant
Glaxosmithkline Consumer Healthcare (Gskch)
1500 Littleton Rd.
Parsippany,  NJ  07054
Applicant Contact WENDY MCMANUS
Correspondent
Glaxosmithkline Consumer Healthcare (Gskch)
1500 Littleton Rd.
Parsippany,  NJ  07054
Correspondent Contact WENDY MCMANUS
Classification Product Code
LFD  
Date Received05/28/2010
Decision Date 09/28/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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