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 ROAD |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
WENDY MCMANUS |
Correspondent |
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
1500 LITTLETON ROAD |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
WENDY MCMANUS |
Classification Product Code |
|
Date Received | 05/28/2010 |
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
|
|
|