The following data is part of a premarket notification filed by Glaxosmithkline Consumer Healthcare, L.p. with the FDA for Oasis Dry Mouth Relief Discs Or Oasis Mouth Moisturizing Discs.
| Device ID | K041563 |
| 510k Number | K041563 |
| Device Name: | OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS |
| Classification | Saliva, Artificial |
| Applicant | GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. 1500 LITTLETON RD. Parsippany, NJ 07054 |
| Contact | Anthony G Amitrano |
| Correspondent | Anthony G Amitrano GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. 1500 LITTLETON RD. 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 | 2004-06-10 |
| Decision Date | 2004-08-27 |
| Summary: | summary |