FDA 510(k)

外科袍

K 號：K213703 · 2022-03-04

申請人Wujiang Tutaike Textiles & Finishing Co., Ltd.

決定日期2022-03-04

產品代碼FYA

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 Gown is the device name listed in this FDA 510(k) record. The listed applicant is Wujiang Tutaike Textiles & Finishing Co., Ltd.. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K213703. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgical Gown?

Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Wujiang Tutaike Textiles & Finishing Co., Ltd.. The 510(k) number is K213703.

When did Surgical Gown receive FDA 510(k) clearance?

Surgical Gown received FDA 510(k) clearance on 2022-03-04, under 510(k) number K213703.

Who is the listed applicant for Surgical Gown?

The FDA 510(k) record lists Wujiang Tutaike Textiles & Finishing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown?

The FDA product code for Surgical Gown is FYA.

其他以 Wujiang Tutaike Textiles & Finishing Co., 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。

K211077外科袍

相關器械（代碼：FYA）

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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