FDA 510(k)

一次性隔離袍 - 等級 3，加大號，藍色，一次性隔離袍 - 等級 3，超加大號，藍色

K 號：K212633 · 2021-11-24

決定日期2021-11-24

產品代碼FYC

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 Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is the device name listed in this FDA 510(k) record. The listed applicant is String King Lacrosse, LLC. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K212633. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is String King Lacrosse, LLC. The 510(k) number is K212633.

When did Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue receive FDA 510(k) clearance?

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue received FDA 510(k) clearance on 2021-11-24, under 510(k) number K212633.

Who is the listed applicant for Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

The FDA 510(k) record lists String King Lacrosse, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue?

The FDA product code for Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue is FYC.

其他以 String King Lacrosse, LLC 為申請人之記錄

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