510(k) K962516— TAP ANTI-SNORING DEVICE

Substantially Equivalent

Nellcor Puritan Bennett, Inc.

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1996-06-27
Decision date: 1996-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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.