LUBRIGEL PERSONAL LUBRICANT— 510(k) K001077
Substantially EquivalentSheffield Laboratories, Div. of Faria Limited, LLC
FDA 510(k) clearance K001077 for LUBRIGEL PERSONAL LUBRICANT, Substantially Equivalent on 2000-08-02. Applicant: Sheffield Laboratories, Div. of Faria Limited, LLC.
Clearance details
- Applicant
- Sheffield Laboratories, Div. of Faria Limited, LLC
- Product code
- Code NUC
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New London, CT, US
Adverse events under product code NUC
product code NUC- Other
- 8
- Total
- 8
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.