XEROSTOM SALIVA SUBSTITUTE GEL— 510(k) K142657

Substantially Equivalent

Bio Cosmetics, S.L.

FDA 510(k) clearance K142657 for XEROSTOM SALIVA SUBSTITUTE GEL, Substantially Equivalent on 2015-09-14. Applicant: Bio Cosmetics, S.L..

Clearance details

Applicant: Bio Cosmetics, S.L.
Product code: Code LFD
Advisory panel: Unknown
Date received: 2014-09-18
Decision date: 2015-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madrid, ES

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.