510(k) K234015 · LFD Saliva, Artificial
Caphosol® Artifical Saliva (32 doses sachet box)
| Applicant | Eusa Pharma (Uk) Limited, Hemel Hempstead, GB |
| Decision | Substantially Equivalent, Mar 11, 2024 |
| Received | Dec 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234015
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2025 | RECORDATI RARE DISEASES INC. Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution
(32 sachets Solution A Phosphate, 32 sachets Solution B Calcium) Open, Classified |
LFD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.