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FDA 510(k)

MEBO Wound Dressing

K-Number: K193439 · 2020-09-04

ApplicantMebo Life Science, Inc.
Decision Date2020-09-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MEBO Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Mebo Life Science, Inc.. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K193439. 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 MEBO Wound Dressing?

MEBO Wound Dressing is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Mebo Life Science, Inc.. The 510(k) number is K193439.

When did MEBO Wound Dressing receive FDA 510(k) clearance?

MEBO Wound Dressing received FDA 510(k) clearance on 2020-09-04, under 510(k) number K193439.

Who is the listed applicant for MEBO Wound Dressing?

The FDA 510(k) record lists Mebo Life Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEBO Wound Dressing?

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

Other records listing Mebo Life Science, Inc. 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.

K222657MEBO Wound 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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