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FDA 510(k)

Sterile Silver Alginate Wound Dressing

K-Number: K220673 · 2023-03-16

ApplicantQingdao Bright Moon Biomedical Materials Co., Ltd.
Decision Date2023-03-16
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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Other records listing Qingdao Bright Moon Biomedical Materials Co., Ltd. as applicant

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Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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