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FDA 510(k)

ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING

K-Number: K973657 · 1997-12-01

ApplicantMaersk Medical, Ltd.
Decision Date1997-12-01
Product CodeMGP
DecisionSubstantially Equivalent for Some Indications

Device Summary

ARGLAES-AB ANTIMICROBIAL BARRIER 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 1997-12-01 under 510(k) number K973657. The device is classified under product code MGP. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING?

ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING is a medical device that received FDA 510(k) clearance on 1997-12-01. The listed applicant is Maersk Medical, Ltd.. The 510(k) number is K973657.

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

ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING received FDA 510(k) clearance on 1997-12-01, under 510(k) number K973657.

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

The FDA product code for ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING is MGP.

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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 DRESSINGK990810ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSINGK970566ARGLAES FILM DRESSING

Related Devices (Code: MGP)

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.

K012995COLLATEK SHEETBiocore Medical Technologies, Inc.K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K001508LASERSKIN DRESSINGFidia Advanced Biopolymers SrlK990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, 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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