Sterile LeadConfirm
K-Number: K191739 · 2020-01-02
Device Summary
Frequently Asked Questions
What is the Sterile LeadConfirm?
Sterile LeadConfirm is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K191739.
When did Sterile LeadConfirm receive FDA 510(k) clearance?
Sterile LeadConfirm received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191739.
Who is the listed applicant for Sterile LeadConfirm?
The FDA 510(k) record lists Alpha Omega Engineering , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterile LeadConfirm?
The FDA product code for Sterile LeadConfirm is GZL.
Other records listing Alpha Omega Engineering , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GZL)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.