PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE— 510(k) K133233
Substantially EquivalentPjur Group Luxembourg S.A.
FDA 510(k) clearance K133233 for PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE, Substantially Equivalent on 2014-07-18. Applicant: Pjur Group Luxembourg S.A..
Clearance details
- Applicant
- Pjur Group Luxembourg S.A.
- Product code
- Code NUC
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, NC, 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.