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FDA 510(k)

Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3

N.º K: K221559 · 2023-02-23

SolicitanteStringking
Fecha de decisión2023-02-23
Código de productoFYA
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Stringking. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K221559. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3?

Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Stringking. The 510(k) number is K221559.

When did Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 receive FDA 510(k) clearance?

Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 received FDA 510(k) clearance on 2023-02-23, under 510(k) number K221559.

Who is the listed applicant for Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3?

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

What is the FDA product code for Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3?

The FDA product code for Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 is FYA.

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Dispositivos relacionados (Código: FYA)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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