ALOCLAIR ORAL GEL— 510(k) K040950

Substantially Equivalent

Sinclair Pharmaceuticals, Ltd.

FDA 510(k) clearance K040950 for ALOCLAIR ORAL GEL, Substantially Equivalent on 2004-06-21. Applicant: Sinclair Pharmaceuticals, Ltd..

Clearance details

Applicant: Sinclair Pharmaceuticals, Ltd.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2004-04-12
Decision date: 2004-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrollton, TX, US

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Adverse events under product code OLR

product code OLR

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.