H&M ANTI-SNORING DEVICE— 510(k) K882303

Substantially Equivalent

Hays & Meade, Inc.

FDA 510(k) clearance K882303 for H&M ANTI-SNORING DEVICE, Substantially Equivalent on 1989-04-14. Applicant: Hays & Meade, Inc..

Clearance details

Applicant: Hays & Meade, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1988-06-03
Decision date: 1989-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, 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.