FDA 510(k)

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber

K 號：K173675 · 2018-07-20

決定日期2018-07-20

產品代碼FRO

決定相當於

器材摘要

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K173675. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber?

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Convatec Limited. The 510(k) number is K173675.

When did AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber receive FDA 510(k) clearance?

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber received FDA 510(k) clearance on 2018-07-20, under 510(k) number K173675.

Who is the listed applicant for AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber?

The FDA 510(k) record lists Convatec Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber?

The FDA product code for AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber is FRO. This falls under the Anesthesiology category.

其他以 Convatec Limited 為申請人之記錄

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相關器械（代碼：FRO）

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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