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FDA 510(k)

外科袍，加強外科袍

K 號：K212861 · 2021-12-15

申請人Wuhan Zonsen Medical Products Co., Ltd.
決定日期2021-12-15
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, Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K212861. 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, Reinforced Surgical Gown?

Surgical Gown, Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K212861.

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

Surgical Gown, Reinforced Surgical Gown received FDA 510(k) clearance on 2021-12-15, under 510(k) number K212861.

Who is the listed applicant for Surgical Gown, Reinforced Surgical Gown?

The FDA 510(k) record lists Wuhan Zonsen Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown, Reinforced Surgical Gown?

The FDA product code for Surgical Gown, Reinforced Surgical Gown is FYA.

相關臨床試驗

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其他以 Wuhan Zonsen Medical Products 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。

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官方來源

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