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FDA 510(k)

AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING

K-Number: K080383 · 2008-05-02

ApplicantConvatec, A Division of E.R. Squibb & Sons, LLC
Decision Date2008-05-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons, LLC. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K080383. 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 AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING?

AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Convatec, A Division of E.R. Squibb & Sons, LLC. The 510(k) number is K080383.

When did AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING receive FDA 510(k) clearance?

AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING received FDA 510(k) clearance on 2008-05-02, under 510(k) number K080383.

Who is the listed applicant for AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING?

The FDA product code for AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Convatec, A Division of E.R. Squibb & Sons, LLC 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.

K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)K063271AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL 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.

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

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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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