FDA 510(k)

Avance 泡沫敷料組合包 - XL

K 號：K161935 · 2016-11-04

決定日期2016-11-04

產品代碼OMP

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

Avance Foam Dressing Kit - XL is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161935. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Avance Foam Dressing Kit - XL?

Avance Foam Dressing Kit - XL is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K161935.

When did Avance Foam Dressing Kit - XL receive FDA 510(k) clearance?

Avance Foam Dressing Kit - XL received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161935.

Who is the listed applicant for Avance Foam Dressing Kit - XL?

The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avance Foam Dressing Kit - XL?

The FDA product code for Avance Foam Dressing Kit - XL is OMP.

其他以 Molnlycke Health Care Us, LLC 為申請人之記錄

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相關器械（代碼：OMP）

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官方來源

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