FDA 510(k)

Sterile Silver Alginate Wound Dressing

Número K: K220673 · 2023-03-16

RequerenteQingdao Bright Moon Biomedical Materials Co., Ltd.

Data da decisão2023-03-16

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Silver Alginate Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Bright Moon Biomedical Materials Co., Ltd.. It received FDA 510(k) clearance on 2023-03-16 under 510(k) number K220673. 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 Sterile Silver Alginate Wound Dressing?

Sterile Silver Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-03-16. The listed applicant is Qingdao Bright Moon Biomedical Materials Co., Ltd.. The 510(k) number is K220673.

When did Sterile Silver Alginate Wound Dressing receive FDA 510(k) clearance?

Sterile Silver Alginate Wound Dressing received FDA 510(k) clearance on 2023-03-16, under 510(k) number K220673.

Who is the listed applicant for Sterile Silver Alginate Wound Dressing?

The FDA 510(k) record lists Qingdao Bright Moon Biomedical Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Silver Alginate Wound Dressing?

The FDA product code for Sterile Silver Alginate Wound Dressing is FRO. This falls under the Anesthesiology category.

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