TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT— 510(k) K060388

Name: FDA 510(k) clearance K060388
Creator: U.S. Food and Drug Administration
Published: 2006-05-17

Substantially Equivalent

Airway Management, Inc.

FDA 510(k) clearance K060388 for TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT, Substantially Equivalent on 2006-05-17. Applicant: Airway Management, Inc.. Device class: 2.

Clearance details

Applicant: Airway Management, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2006-02-14
Decision date: 2006-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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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.