GELCLAIR CONCENTRATED ORAL GEL— 510(k) K013056

Substantially Equivalent

Sinclair Pharmaceuticals, Ltd.

FDA 510(k) clearance K013056 for GELCLAIR CONCENTRATED ORAL GEL, Substantially Equivalent on 2001-12-21. Applicant: Sinclair Pharmaceuticals, Ltd..

Clearance details

Applicant: Sinclair Pharmaceuticals, Ltd.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2001-09-11
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chinley, High Peak, 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.