NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER— 510(k) K013687

Substantially Equivalent

Steven K. Sue

FDA 510(k) clearance K013687 for NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER, Substantially Equivalent on 2002-05-28. Applicant: Steven K. Sue.

Clearance details

Applicant: Steven K. Sue
Product code: Code LRK
Advisory panel: Dental
Date received: 2001-11-07
Decision date: 2002-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Honolulu, HI, 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.