FDA 510(k)

LT Antibacterial Alginate with Silver Dressing

Número K: K192478 · 2020-06-17

RequerenteZhejiang Longterm Medical Technology Co., Ltd.

Data da decisão2020-06-17

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

LT Antibacterial Alginate with Silver Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K192478. 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 LT Antibacterial Alginate with Silver Dressing?

LT Antibacterial Alginate with Silver Dressing is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K192478.

When did LT Antibacterial Alginate with Silver Dressing receive FDA 510(k) clearance?

LT Antibacterial Alginate with Silver Dressing received FDA 510(k) clearance on 2020-06-17, under 510(k) number K192478.

Who is the listed applicant for LT Antibacterial Alginate with Silver Dressing?

The FDA 510(k) record lists Zhejiang Longterm Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LT Antibacterial Alginate with Silver Dressing?

The FDA product code for LT Antibacterial Alginate with Silver Dressing is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Zhejiang Longterm Medical Technology Co., Ltd. como candidato(a)

K254246LT Antibacterial Foam with Silver Dressing K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit K202823Innomed NPWT Silicone Foam Dressing K182458Longterm NPWT Foam Dressing Kit

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