ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING— 510(k) K990810

Name: FDA 510(k) clearance K990810
Creator: U.S. Food and Drug Administration
Published: 1999-09-17

Substantially Equivalent

Maersk Medical, Ltd.

FDA 510(k) clearance K990810 for ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING, Substantially Equivalent on 1999-09-17. Applicant: Maersk Medical, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Maersk Medical, Ltd.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-03-11
Decision date: 1999-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Louis, MO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Maersk Medical, Ltd.

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K004028 — ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING2001-03-27
K973657 — ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING1997-12-01
K970566 — ARGLAES FILM DRESSING1997-07-29

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.