Sterile LeadConfirm
K-Number: K191739 · 2020-01-02
ApplicantAlpha Omega Engineering , Ltd.
Decision Date2020-01-02
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Sterile LeadConfirm is a medical device manufactured by Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2020-01-02 under approval number K191739. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sterile LeadConfirm?
Sterile LeadConfirm is a medical device that received FDA 510(k) clearance on 2020-01-02. It is manufactured by Alpha Omega Engineering , Ltd.. The 510(k) number is K191739.
When was Sterile LeadConfirm approved by the FDA?
Sterile LeadConfirm received FDA 510(k) clearance on 2020-01-02, under approval number K191739.
What company makes Sterile LeadConfirm?
Sterile LeadConfirm is manufactured by Alpha Omega Engineering , Ltd..
What is the FDA product code for Sterile LeadConfirm?
The FDA product code for Sterile LeadConfirm is GZL.
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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.