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FDA 510(k)

Copper Foam Dressing (Prescription and OTC)

K-Number: K231088 · 2024-01-11

ApplicantRoosin Medical Co., Ltd.
Decision Date2024-01-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Copper Foam Dressing (Prescription and OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K231088. 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 Copper Foam Dressing (Prescription and OTC)?

Copper Foam Dressing (Prescription and OTC) is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Roosin Medical Co., Ltd.. The 510(k) number is K231088.

When did Copper Foam Dressing (Prescription and OTC) receive FDA 510(k) clearance?

Copper Foam Dressing (Prescription and OTC) received FDA 510(k) clearance on 2024-01-11, under 510(k) number K231088.

Who is the listed applicant for Copper Foam Dressing (Prescription and OTC)?

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

What is the FDA product code for Copper Foam Dressing (Prescription and OTC)?

The FDA product code for Copper Foam Dressing (Prescription and OTC) is FRO. This falls under the Anesthesiology category.

Other records listing Roosin Medical Co., Ltd. as applicant

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.

K254034Roosin Collagen PowderK253974Roosin Collagen DressingK230190Polyver Silver Alginate Dressing (Prescription and OTC)K181478Roosin Xeroform Petrolatum Dressing

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

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

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