pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
FDA 510(k) clearance K200731 · decided 2021-01-21
Clearance details
- K-number
- K200731
- Device name
- pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
- Applicant
- Pjur Group Luxembourg S.A.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-20
- Decision date
- 2021-01-21
- Days to decision
- 307 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Wasserbillig, LU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.