pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5— 510(k) K200731

Substantially Equivalent

Pjur Group Luxembourg S.A.

FDA 510(k) clearance K200731 for pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5, Substantially Equivalent on 2021-01-21. Applicant: Pjur Group Luxembourg S.A.. Device class: 2.

Clearance details

Applicant
Pjur Group Luxembourg S.A.
Product code
Code NUC
Device class
Class 2
Regulation
21 CFR 884.5300
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wasserbillig, LU
Download summary PDFView on FDA.gov ↗

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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.