LOWE KLEARWAY— 510(k) K950763

Substantially Equivalent

Dr. Alan A. Lowe, Inc.

FDA 510(k) clearance K950763 for LOWE KLEARWAY, Substantially Equivalent on 1995-05-25. Applicant: Dr. Alan A. Lowe, Inc..

Clearance details

Applicant: Dr. Alan A. Lowe, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1995-02-17
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, B.C. V6k 4m1, CA

Download summary PDF View on FDA.gov ↗

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.