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FDA 510(k)

Antibacterial Bandage

K-Number: K201324 · 2021-02-05

ApplicantJiangsu Excellence Medical Supplies Co., Ltd.
Decision Date2021-02-05
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Antibacterial Bandage is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Excellence Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K201324. 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 Antibacterial Bandage?

Antibacterial Bandage is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Jiangsu Excellence Medical Supplies Co., Ltd.. The 510(k) number is K201324.

When did Antibacterial Bandage receive FDA 510(k) clearance?

Antibacterial Bandage received FDA 510(k) clearance on 2021-02-05, under 510(k) number K201324.

Who is the listed applicant for Antibacterial Bandage?

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

What is the FDA product code for Antibacterial Bandage?

The FDA product code for Antibacterial Bandage is FRO. This falls under the Anesthesiology category.

Other records listing Jiangsu Excellence Medical Supplies 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.

K202905Disposable Face Mask

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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