FDA 510(k)

Vestido hidrófobo AQUACEL Ag+ EXTRA con fibra de refuerzo

N.º K: K173675 · 2018-07-20

Fecha de decisión2018-07-20

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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