The following data is part of a premarket notification filed by Glaxosmithkline Consumer Healthcare (gskch) with the FDA for Biotene Dry Mouth Mouthwash, Biotene Pbf Dry Mouth Mouthwash.
| Device ID | K101477 |
| 510k Number | K101477 |
| Device Name: | BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH |
| Classification | Saliva, Artificial |
| Applicant | GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) 1500 LITTLETON ROAD Parsippany, NJ 07054 |
| Contact | Wendy Mcmanus |
| Correspondent | Wendy Mcmanus GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) 1500 LITTLETON ROAD Parsippany, NJ 07054 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-28 |
| Decision Date | 2010-09-28 |
| Summary: | summary |