Sterile LeadConfirm— 510(k) K191739

Substantially Equivalent

Alpha Omega Engineering , Ltd.

FDA 510(k) clearance K191739 for Sterile LeadConfirm, Substantially Equivalent on 2020-01-02. Applicant: Alpha Omega Engineering , Ltd..

Clearance details

Applicant: Alpha Omega Engineering , Ltd.
Product code: Code GZL
Advisory panel: Neurology
Date received: 2019-06-28
Decision date: 2020-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth, IL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.