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FDA 510(k)

anti-bacterial bandage

K-Number: K200821 · 2020-10-19

ApplicantPlanet (Suzhou) Medical Products Co., Ltd.
Decision Date2020-10-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

anti-bacterial bandage is the device name listed in this FDA 510(k) record. The listed applicant is Planet (Suzhou) Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K200821. 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 anti-bacterial bandage?

anti-bacterial bandage is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Planet (Suzhou) Medical Products Co., Ltd.. The 510(k) number is K200821.

When did anti-bacterial bandage receive FDA 510(k) clearance?

anti-bacterial bandage received FDA 510(k) clearance on 2020-10-19, under 510(k) number K200821.

Who is the listed applicant for anti-bacterial bandage?

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

What is the FDA product code for anti-bacterial bandage?

The FDA product code for anti-bacterial bandage is FRO. This falls under the Anesthesiology category.

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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