OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS— 510(k) K041563

Substantially Equivalent

Glaxosmithkline Consumer Healthcare, L.P.

FDA 510(k) clearance K041563 for OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS, Substantially Equivalent on 2004-08-27. Applicant: Glaxosmithkline Consumer Healthcare, L.P..

Clearance details

Applicant: Glaxosmithkline Consumer Healthcare, L.P.
Product code: Code LFD
Advisory panel: Unknown
Date received: 2004-06-10
Decision date: 2004-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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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.