FDA 510(k)

High Performance Antimicrobial Gelling Fiber with Silver

Número K: K210974 · 2021-05-12

RequerenteAdvanced Medical Solutions, Ltd.

Data da decisão2021-05-12

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

High Performance Antimicrobial Gelling Fiber with Silver 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 2021-05-12 under 510(k) number K210974. 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 High Performance Antimicrobial Gelling Fiber with Silver?

High Performance Antimicrobial Gelling Fiber with Silver is a medical device that received FDA 510(k) clearance on 2021-05-12. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K210974.

When did High Performance Antimicrobial Gelling Fiber with Silver receive FDA 510(k) clearance?

High Performance Antimicrobial Gelling Fiber with Silver received FDA 510(k) clearance on 2021-05-12, under 510(k) number K210974.

Who is the listed applicant for High Performance Antimicrobial Gelling Fiber with Silver?

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 High Performance Antimicrobial Gelling Fiber with Silver?

The FDA product code for High Performance Antimicrobial Gelling Fiber with Silver is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Advanced Medical Solutions, Ltd. como candidato(a)

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Fonte oficial

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