ALOCLAIR ORAL RINSE— 510(k) K023155

Substantially Equivalent

Sinclair Pharmaceuticals, Ltd.

FDA 510(k) clearance K023155 for ALOCLAIR ORAL RINSE, Substantially Equivalent on 2002-11-25. Applicant: Sinclair Pharmaceuticals, Ltd..

Clearance details

Applicant: Sinclair Pharmaceuticals, Ltd.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2002-09-23
Decision date: 2002-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Godalming, Surrey, GB

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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.