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FDA 510(k)

HYDROFERA BACTERIOSTATIC WOUND DRESSING

K-Number: K013462 · 2002-01-11

ApplicantHydrofera, LLC
Decision Date2002-01-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HYDROFERA BACTERIOSTATIC WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Hydrofera, LLC. It received FDA 510(k) clearance on 2002-01-11 under 510(k) number K013462. 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 HYDROFERA BACTERIOSTATIC WOUND DRESSING?

HYDROFERA BACTERIOSTATIC WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2002-01-11. The listed applicant is Hydrofera, LLC. The 510(k) number is K013462.

When did HYDROFERA BACTERIOSTATIC WOUND DRESSING receive FDA 510(k) clearance?

HYDROFERA BACTERIOSTATIC WOUND DRESSING received FDA 510(k) clearance on 2002-01-11, under 510(k) number K013462.

Who is the listed applicant for HYDROFERA BACTERIOSTATIC WOUND DRESSING?

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

What is the FDA product code for HYDROFERA BACTERIOSTATIC WOUND DRESSING?

The FDA product code for HYDROFERA BACTERIOSTATIC WOUND DRESSING is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

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Other records listing Hydrofera, 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.

K190268Hydrofera Blue READY - BorderK023138HYDROFERA BACTERIOSTATIC WOUND DRESSINGK983276HYDROFERA BACTERISTATIC NASAL DRESSINGK974313HYDROFERA SURGICAL SPEARK974316HYDROFERA FEMORAL WICK

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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