BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)— 510(k) K113836

Substantially Equivalent

Avery Dennison Belgie Bvba

FDA 510(k) clearance K113836 for BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM), Substantially Equivalent on 2012-09-24. Applicant: Avery Dennison Belgie Bvba.

Clearance details

Applicant: Avery Dennison Belgie Bvba
Product code: Code FRO
Advisory panel: Unknown
Date received: 2011-12-28
Decision date: 2012-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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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.