The following data is part of a premarket notification filed by Parnell Pharmaceuticals, Inc. with the FDA for Mouthkote Oral Moisturizer, Model 50930-098.
| Device ID | K062653 |
| 510k Number | K062653 |
| Device Name: | MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 |
| Classification | Saliva, Artificial |
| Applicant | PARNELL PHARMACEUTICALS, INC. 1525 FRANCISCO BLVD., STE. 15 San Rafael, CA 94901 |
| Contact | Francis W Parnell |
| Correspondent | Francis W Parnell PARNELL PHARMACEUTICALS, INC. 1525 FRANCISCO BLVD., STE. 15 San Rafael, CA 94901 |
| 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 | 2006-09-07 |
| Decision Date | 2006-10-27 |
| Summary: | summary |