FDA 510(k)

pjur AQUA Baseline，pjur AQUA Guarana，pjur AQUA ProVitamin B5，pjur BACK DOOR anal Provitamin B5

K号: K200731 · 2021-01-21

决定日期2021-01-21

产品代码NUC

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决定实质等同

器械摘要

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 is the device name listed in this FDA 510(k) record. The listed applicant is Pjur Group Luxembourg S.A.. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K200731. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5?

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Pjur Group Luxembourg S.A.. The 510(k) number is K200731.

When did pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 receive FDA 510(k) clearance?

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 received FDA 510(k) clearance on 2021-01-21, under 510(k) number K200731.

Who is the listed applicant for pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5?

The FDA 510(k) record lists Pjur Group Luxembourg S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5?

The FDA product code for pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 is NUC.

列明Pjur Group Luxembourg S.A.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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