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FDA 510(k)

防磨保護器

K 號:K240810 · 2024-05-24

決定日期2024-05-24
產品代碼OBR
決定相當於

器材摘要

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.

常見問題

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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相關器械(代碼:OBR)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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