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FDA 510(k)

ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING

K-Number: K990810 · 1999-09-17

ApplicantMaersk Medical, Ltd.
Decision Date1999-09-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND 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 1999-09-17 under 510(k) number K990810. 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 FILM DRESSING & ISLAND DRESSING?

ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING is a medical device that received FDA 510(k) clearance on 1999-09-17. The listed applicant is Maersk Medical, Ltd.. The 510(k) number is K990810.

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

ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING received FDA 510(k) clearance on 1999-09-17, under 510(k) number K990810.

Who is the listed applicant for ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND 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 FILM DRESSING & ISLAND DRESSING?

The FDA product code for ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND 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.

K004028ARGLAES-AB ANTIMICROBIAL BARRIER POWDER 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

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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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