BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF


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

Correspodent Contact wendy a mcmanus
Classification Product Code
LFD  
Date Received 12/23/2010
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