ADJUSTABLE SOFT PALATE LIFTER— 510(k) K895189

Name: FDA 510(k) clearance K895189
Creator: U.S. Food and Drug Administration
Published: 1990-02-09

Substantially Equivalent

Ortho Publications, Inc.

FDA 510(k) clearance K895189 for ADJUSTABLE SOFT PALATE LIFTER, Substantially Equivalent on 1990-02-09. Applicant: Ortho Publications, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Publications, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 1989-08-11
Decision date: 1990-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westfield, NJ, 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.