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FDA 510(k)

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops

Número K: K221209 · 2023-03-08

RequerentePadm Medical, Inc.
Data da decisão2023-03-08
Código do produtoFXX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is the device name listed in this FDA 510(k) record. The listed applicant is Padm Medical, Inc.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K221209. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Padm Medical, Inc.. The 510(k) number is K221209.

When did PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops receive FDA 510(k) clearance?

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops received FDA 510(k) clearance on 2023-03-08, under 510(k) number K221209.

Who is the listed applicant for PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

The FDA 510(k) record lists Padm Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

The FDA product code for PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is FXX.

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Dispositivos Relacionados (Código: FXX)

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