FDA 510(k)

Exufiber Ag+

Número K: K160379 · 2016-08-25

Data da decisão2016-08-25

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Exufiber Ag+ 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 2016-08-25 under 510(k) number K160379. 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.

Perguntas frequentes

What is the Exufiber Ag+?

Exufiber Ag+ is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K160379.

When did Exufiber Ag+ receive FDA 510(k) clearance?

Exufiber Ag+ received FDA 510(k) clearance on 2016-08-25, under 510(k) number K160379.

Who is the listed applicant for Exufiber Ag+?

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 Exufiber Ag+?

The FDA product code for Exufiber Ag+ is FRO. This falls under the Anesthesiology category.

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