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FDA 510(k)

URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER

K-Number: K062559 · 2007-01-29

ApplicantLaboratoires Urgo
Decision Date2007-01-29
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER is the device name listed in this FDA 510(k) record. The listed applicant is Laboratoires Urgo. It received FDA 510(k) clearance on 2007-01-29 under 510(k) number K062559. 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 URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER?

URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER is a medical device that received FDA 510(k) clearance on 2007-01-29. The listed applicant is Laboratoires Urgo. The 510(k) number is K062559.

When did URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER receive FDA 510(k) clearance?

URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER received FDA 510(k) clearance on 2007-01-29, under 510(k) number K062559.

Who is the listed applicant for URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER?

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

What is the FDA product code for URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER?

The FDA product code for URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Laboratoires Urgo 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.

K123219URGOCLEAN ABSORBENT WOUND DRESSINGK100429URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVERK100430URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVERK061220URGOTUL AG

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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