FDA 510(k)

Dream Medi Sterile Surgical Gown (SurgicalGownUL)

N.º K: K242937 · 2025-05-05

SolicitanteDae Myung Chemical Co., Ltd. (Vietnam)

Fecha de decisión2025-05-05

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dream Medi Sterile Surgical Gown (SurgicalGownUL) is the device name listed in this FDA 510(k) record. The listed applicant is Dae Myung Chemical Co., Ltd. (Vietnam). It received FDA 510(k) clearance on 2025-05-05 under 510(k) number K242937. 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 Dream Medi Sterile Surgical Gown (SurgicalGownUL)?

Dream Medi Sterile Surgical Gown (SurgicalGownUL) is a medical device that received FDA 510(k) clearance on 2025-05-05. The listed applicant is Dae Myung Chemical Co., Ltd. (Vietnam). The 510(k) number is K242937.

When did Dream Medi Sterile Surgical Gown (SurgicalGownUL) receive FDA 510(k) clearance?

Dream Medi Sterile Surgical Gown (SurgicalGownUL) received FDA 510(k) clearance on 2025-05-05, under 510(k) number K242937.

Who is the listed applicant for Dream Medi Sterile Surgical Gown (SurgicalGownUL)?

The FDA 510(k) record lists Dae Myung Chemical Co., Ltd. (Vietnam) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dream Medi Sterile Surgical Gown (SurgicalGownUL)?

The FDA product code for Dream Medi Sterile Surgical Gown (SurgicalGownUL) is FYA.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: FYA)

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Fuente oficial

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