FDA 510(k)

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3

Número K: K211066 · 2021-08-19

Data da decisão2021-08-19

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 is the device name listed in this FDA 510(k) record. The listed applicant is Homtex, Inc.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211066. 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 Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3?

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Homtex, Inc.. The 510(k) number is K211066.

When did Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 receive FDA 510(k) clearance?

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211066.

Who is the listed applicant for Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3?

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

What is the FDA product code for Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3?

The FDA product code for Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 is FXX.

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Outros registros que listam Homtex, Inc. como candidato(a)

K201095Sovereign America Surgical Face Mask

Dispositivos Relacionados (Código: FXX)

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