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FDA 510(k)

ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING

K-Number: K004028 · 2001-03-27

ApplicantMaersk Medical, Ltd.
Decision Date2001-03-27
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Maersk Medical, Ltd.. It received FDA 510(k) clearance on 2001-03-27 under 510(k) number K004028. 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 ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING?

ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING is a medical device that received FDA 510(k) clearance on 2001-03-27. The listed applicant is Maersk Medical, Ltd.. The 510(k) number is K004028.

When did ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING receive FDA 510(k) clearance?

ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING received FDA 510(k) clearance on 2001-03-27, under 510(k) number K004028.

Who is the listed applicant for ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING?

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

What is the FDA product code for ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING?

The FDA product code for ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Maersk Medical, Ltd. 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.

K990810ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSINGK973657ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSINGK970566ARGLAES FILM 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.

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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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