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FDA 510(k)

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

N.º K: K230395 · 2023-07-17

SolicitanteDurio Ppe Sdn Bhd
Fecha de decisión2023-07-17
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is the device name listed in this FDA 510(k) record. The listed applicant is Durio Ppe Sdn Bhd. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230395. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Durio Ppe Sdn Bhd. The 510(k) number is K230395.

When did Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) receive FDA 510(k) clearance?

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230395.

Who is the listed applicant for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

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

What is the FDA product code for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

The FDA product code for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is FXX.

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Fuente oficial

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