Nexus Universal Self-Cure
K-Number: K191548 · 2019-10-11
ApplicantKerr Corporation
Decision Date2019-10-11
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Nexus Universal Self-Cure is a medical device manufactured by Kerr Corporation. It received FDA 510(k) clearance on 2019-10-11 under approval number K191548. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nexus Universal Self-Cure?
Nexus Universal Self-Cure is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Kerr Corporation. The 510(k) number is K191548.
When was Nexus Universal Self-Cure approved by the FDA?
Nexus Universal Self-Cure received FDA 510(k) clearance on 2019-10-11, under approval number K191548.
What company makes Nexus Universal Self-Cure?
Nexus Universal Self-Cure is manufactured by Kerr Corporation.
What is the FDA product code for Nexus Universal Self-Cure?
The FDA product code for Nexus Universal Self-Cure is EMA.
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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.