Caphosol® Artifical Saliva (32 doses sachet box)— 510(k) K234015

Substantially Equivalent

Eusa Pharma (Uk) Limited

FDA 510(k) clearance K234015 for Caphosol® Artifical Saliva (32 doses sachet box), Substantially Equivalent on 2024-03-11. Applicant: Eusa Pharma (Uk) Limited.

Clearance details

Applicant: Eusa Pharma (Uk) Limited
Product code: Code LFD
Advisory panel: Unknown
Date received: 2023-12-19
Decision date: 2024-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hemel Hempstead, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.