FDA 510(k)

外科口罩（型號：平面耳環/CN102）

K 號：K203534 · 2021-07-21

申請人Crown Name Disposable Hygiene Products Fty., Ltd.

決定日期2021-07-21

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

Surgical face mask (Model: Flat Ear Loop/CN102) is the device name listed in this FDA 510(k) record. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K203534. 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 Surgical face mask (Model: Flat Ear Loop/CN102)?

Surgical face mask (Model: Flat Ear Loop/CN102) is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. The 510(k) number is K203534.

When did Surgical face mask (Model: Flat Ear Loop/CN102) receive FDA 510(k) clearance?

Surgical face mask (Model: Flat Ear Loop/CN102) received FDA 510(k) clearance on 2021-07-21, under 510(k) number K203534.

Who is the listed applicant for Surgical face mask (Model: Flat Ear Loop/CN102)?

The FDA 510(k) record lists Crown Name Disposable Hygiene Products Fty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical face mask (Model: Flat Ear Loop/CN102)?

The FDA product code for Surgical face mask (Model: Flat Ear Loop/CN102) is FXX.

其他以 Crown Name Disposable Hygiene Products Fty., Ltd. 為申請人之記錄

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。

K212422一次性外科隔離衣

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。

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官方來源

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