FDA 510(k)

外科袍

K 號：K211509 · 2021-10-24

申請人Hubei Wanli Protective Products Co., Ltd.

決定日期2021-10-24

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 Hubei Wanli Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2021-10-24 under 510(k) number K211509. 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 2021-10-24. The listed applicant is Hubei Wanli Protective Products Co., Ltd.. The 510(k) number is K211509.

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

Surgical Gown received FDA 510(k) clearance on 2021-10-24, under 510(k) number K211509.

Who is the listed applicant for Surgical Gown?

The FDA 510(k) record lists Hubei Wanli Protective Products 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 Hubei Wanli Protective Products Co., Ltd. 為申請人之記錄

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官方來源

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