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FDA 510(k)

KERATEC WOUND DRESSINGS

K-Number: K080949 · 2009-02-11

ApplicantKeratec Limited
Decision Date2009-02-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

KERATEC WOUND DRESSINGS is the device name listed in this FDA 510(k) record. The listed applicant is Keratec Limited. It received FDA 510(k) clearance on 2009-02-11 under 510(k) number K080949. 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 KERATEC WOUND DRESSINGS?

KERATEC WOUND DRESSINGS is a medical device that received FDA 510(k) clearance on 2009-02-11. The listed applicant is Keratec Limited. The 510(k) number is K080949.

When did KERATEC WOUND DRESSINGS receive FDA 510(k) clearance?

KERATEC WOUND DRESSINGS received FDA 510(k) clearance on 2009-02-11, under 510(k) number K080949.

Who is the listed applicant for KERATEC WOUND DRESSINGS?

The FDA 510(k) record lists Keratec Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KERATEC WOUND DRESSINGS?

The FDA product code for KERATEC WOUND DRESSINGS is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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