BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH— 510(k) K101477
Substantially EquivalentGlaxosmithkline Consumer Healthcare (Gskch)
FDA 510(k) clearance K101477 for BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH, Substantially Equivalent on 2010-09-28. Applicant: Glaxosmithkline Consumer Healthcare (Gskch).
Clearance details
- Applicant
- Glaxosmithkline Consumer Healthcare (Gskch)
- Product code
- Code LFD
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
Adverse events under product code LFD
product code LFD- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.