FDA 510(k)

Guarda contra o Desgaste

Número K: K240810 · 2024-05-24

RequerenteXiamen Yizhou Imp. & Exp. Co., Ltd.

Data da decisão2024-05-24

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anti Grinding Guard is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Yizhou Imp. & Exp. Co., Ltd.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K240810. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anti Grinding Guard?

Anti Grinding Guard is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Xiamen Yizhou Imp. & Exp. Co., Ltd.. The 510(k) number is K240810.

When did Anti Grinding Guard receive FDA 510(k) clearance?

Anti Grinding Guard received FDA 510(k) clearance on 2024-05-24, under 510(k) number K240810.

Who is the listed applicant for Anti Grinding Guard?

The FDA 510(k) record lists Xiamen Yizhou Imp. & Exp. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anti Grinding Guard?

The FDA product code for Anti Grinding Guard is OBR. This falls under the Orthopedic category.

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