CFR MONOGRAPH— 510(k) K925259

Substantially Equivalent

Combe, Inc.

FDA 510(k) clearance K925259 for CFR MONOGRAPH, Substantially Equivalent on 1993-01-11. Applicant: Combe, Inc..

Clearance details

Applicant: Combe, Inc.
Product code: Code EFT
Advisory panel: Dental
Date received: 1992-10-19
Decision date: 1993-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.