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FDA 510(k)

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

K-Number: K213400 · 2022-03-01

Decision Date2022-03-01
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us). It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K213400. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry?

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Rb Health (Us). The 510(k) number is K213400.

When did Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry receive FDA 510(k) clearance?

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry received FDA 510(k) clearance on 2022-03-01, under 510(k) number K213400.

Who is the listed applicant for Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry?

The FDA 510(k) record lists Rb Health (Us) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry?

The FDA product code for Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry is NUC.

Other records listing Rb Health (Us) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 15 devices →

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.