K162167 is an FDA 510(k) clearance for the Caphosol Artifical Saliva Tablets. This device is classified as a Saliva, Artificial.
Submitted by Eusa Pharma (Uk) Limited (Hemel Hempstead, GB). The FDA issued a Cleared decision on March 31, 2017, 240 days after receiving the submission on August 3, 2016.
This device falls under the Dental FDA review panel.
| 510(k) Number | K162167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2016 |
| Decision Date | March 31, 2017 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD — Saliva, Artificial |
| Device Class | — |