ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING— 510(k) K973657

Name: FDA 510(k) clearance K973657
Creator: U.S. Food and Drug Administration
Published: 1997-12-01

Substantially Equivalent for Some Indications

Maersk Medical, Ltd.

FDA 510(k) clearance K973657 for ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING, Substantially Equivalent for Some Indications on 1997-12-01. Applicant: Maersk Medical, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Maersk Medical, Ltd.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-09-25
Decision date: 1997-12-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: St Louis, MO, US

Download summary PDF View on FDA.gov ↗

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K001508 — LASERSKIN DRESSING2001-07-25
K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

More clearances from Maersk Medical, Ltd.

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K004028 — ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING2001-03-27
K990810 — ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING1999-09-17
K970566 — ARGLAES FILM DRESSING1997-07-29

Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.