K234015 is an FDA 510(k) clearance for the Caphosol® Artifical Saliva (32 doses sachet box). 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 11, 2024, 83 days after receiving the submission on December 19, 2023.
This device falls under the Dental FDA review panel.
| 510(k) Number | K234015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2023 |
| Decision Date | March 11, 2024 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD - Saliva, Artificial |
| Device Class | - |