The following data is part of a premarket notification filed by Eusa Pharma (uk) Limited with the FDA for Caphosol Artifical Saliva Tablets.
| Device ID | K162167 |
| 510k Number | K162167 |
| Device Name: | Caphosol Artifical Saliva Tablets |
| Classification | Saliva, Artificial |
| Applicant | EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way Hemel Hempstead, GB Hp2-4tz |
| Contact | Paul Davisson |
| Correspondent | J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071 -3404 |
| 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 | 2016-08-03 |
| Decision Date | 2017-03-31 |
| Summary: | summary |