510(k) K863399— BYRON DORSAL COLUMELLA IMPLANT

Substantially Equivalent

Byron Medical

Clearance details

Applicant: Byron Medical
Product code: Code FZE
Advisory panel: General, Plastic Surgery
Date received: 1986-09-03
Decision date: 1986-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.