BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF— 510(k) K103745

Substantially Equivalent

Glaxosmithkline Consumer Healthcare (Gskch)

FDA 510(k) clearance K103745 for BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF, Substantially Equivalent on 2011-07-20. Applicant: Glaxosmithkline Consumer Healthcare (Gskch).

Clearance details

Applicant: Glaxosmithkline Consumer Healthcare (Gskch)
Product code: Code LFD
Advisory panel: Unknown
Date received: 2010-12-23
Decision date: 2011-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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.