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FDA 510(k)

一次性四層外科口罩

K 號:K230093 · 2023-03-02

決定日期2023-03-02
產品代碼FXX
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Disposable 4 Layers Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Social Medical Supply, LLC. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K230093. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable 4 Layers Surgical Face Mask?

Disposable 4 Layers Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Social Medical Supply, LLC. The 510(k) number is K230093.

When did Disposable 4 Layers Surgical Face Mask receive FDA 510(k) clearance?

Disposable 4 Layers Surgical Face Mask received FDA 510(k) clearance on 2023-03-02, under 510(k) number K230093.

Who is the listed applicant for Disposable 4 Layers Surgical Face Mask?

The FDA 510(k) record lists Social Medical Supply, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable 4 Layers Surgical Face Mask?

The FDA product code for Disposable 4 Layers Surgical Face Mask is FXX.

相關臨床試驗

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相關器械(代碼:FXX)

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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