FDA 510(k)

Silverlon Wound Contact, Burn Contact Dressings

Número K: K221218 · 2022-10-26

Data da decisão2022-10-26

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Silverlon Wound Contact, Burn Contact Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Argentum Medical, Inc.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K221218. 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 Silverlon Wound Contact, Burn Contact Dressings?

Silverlon Wound Contact, Burn Contact Dressings is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Argentum Medical, Inc.. The 510(k) number is K221218.

When did Silverlon Wound Contact, Burn Contact Dressings receive FDA 510(k) clearance?

Silverlon Wound Contact, Burn Contact Dressings received FDA 510(k) clearance on 2022-10-26, under 510(k) number K221218.

Who is the listed applicant for Silverlon Wound Contact, Burn Contact Dressings?

The FDA 510(k) record lists Argentum Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silverlon Wound Contact, Burn Contact Dressings?

The FDA product code for Silverlon Wound Contact, Burn Contact Dressings is FRO. This falls under the Anesthesiology category.

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