Sterile LeadConfirm— 510(k) K191739

Name: FDA 510(k) clearance K191739
Creator: U.S. Food and Drug Administration
Published: 2020-01-02

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.. Device class: 2.

Clearance details

Applicant: Alpha Omega Engineering , Ltd.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
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 ↗

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