DISTRAX— 510(k) K080542

Substantially Equivalent

John W. King

FDA 510(k) clearance K080542 for DISTRAX, Substantially Equivalent on 2008-12-15. Applicant: John W. King.

Clearance details

Applicant: John W. King
Product code: Code MQN
Advisory panel: Dental
Date received: 2008-02-27
Decision date: 2008-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

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.