NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE— 510(k) K013049

Substantially Equivalent

Dennis R. Bailey, Dds

FDA 510(k) clearance K013049 for NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE, Substantially Equivalent on 2001-11-29. Applicant: Dennis R. Bailey, Dds.

Clearance details

Applicant: Dennis R. Bailey, Dds
Product code: Code LRK
Advisory panel: Dental
Date received: 2001-09-11
Decision date: 2001-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.