ARGLAES FILM DRESSING— 510(k) K970566

Substantially Equivalent for Some Indications

Maersk Medical, Ltd.

FDA 510(k) clearance K970566 for ARGLAES FILM DRESSING, Substantially Equivalent for Some Indications on 1997-07-29. Applicant: Maersk Medical, Ltd..

Clearance details

Applicant: Maersk Medical, Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1997-02-13
Decision date: 1997-07-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Redditch, Worcestershire, GB

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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.