TRAV-LER KIT— 510(k) K943942

Unknown

John O. Butler Co.

FDA 510(k) clearance K943942 for TRAV-LER KIT, Unknown on 1995-03-08. Applicant: John O. Butler Co..

Clearance details

Applicant: John O. Butler Co.
Product code: Code JEQ
Advisory panel: Dental
Date received: 1994-08-12
Decision date: 1995-03-08
Decision: Unknown
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code JEQ

product code JEQ

Injury: 188
Malfunction: 2,818
Total: 3,006

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.