510(k) K042722— ALOCLAIR ORAL SPRAY

Substantially Equivalent

Sinclair Pharmaceuticals, Ltd.

Clearance details

Applicant: Sinclair Pharmaceuticals, Ltd.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2004-10-01
Decision date: 2005-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Godalming, Surrey, GB

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.