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

Name: FDA 510(k) clearance K041563
Creator: U.S. Food and Drug Administration
Published: 2004-08-27

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.. Device class: Unclassified.

Clearance details

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

Download summary PDF View on FDA.gov ↗

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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.