FDA 510(k)

Surgical Silver Post Operative Dressing

Número K: K180634 · 2018-08-07

RequerenteAdvanced Medical Solutions, Ltd.

Data da decisão2018-08-07

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Silver Post Operative Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2018-08-07 under 510(k) number K180634. 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 Surgical Silver Post Operative Dressing?

Surgical Silver Post Operative Dressing is a medical device that received FDA 510(k) clearance on 2018-08-07. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K180634.

When did Surgical Silver Post Operative Dressing receive FDA 510(k) clearance?

Surgical Silver Post Operative Dressing received FDA 510(k) clearance on 2018-08-07, under 510(k) number K180634.

Who is the listed applicant for Surgical Silver Post Operative Dressing?

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

What is the FDA product code for Surgical Silver Post Operative Dressing?

The FDA product code for Surgical Silver Post Operative Dressing is FRO. This falls under the Anesthesiology category.

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Fonte oficial

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