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FDA 510(k)

Omnia Medical TiBrid-SA

K-Number: K203207 · 2020-12-23

Decision Date2020-12-23
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Omnia Medical TiBrid-SA is a medical device manufactured by Omnia Medical, LLC. It received FDA 510(k) clearance on 2020-12-23 under approval number K203207. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnia Medical TiBrid-SA?

Omnia Medical TiBrid-SA is a medical device that received FDA 510(k) clearance on 2020-12-23. It is manufactured by Omnia Medical, LLC. The 510(k) number is K203207.

When was Omnia Medical TiBrid-SA approved by the FDA?

Omnia Medical TiBrid-SA received FDA 510(k) clearance on 2020-12-23, under approval number K203207.

What company makes Omnia Medical TiBrid-SA?

Omnia Medical TiBrid-SA is manufactured by Omnia Medical, LLC.

What is the FDA product code for Omnia Medical TiBrid-SA?

The FDA product code for Omnia Medical TiBrid-SA is OVD.

Other Devices by Omnia Medical, LLC

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Related Devices (Code: OVD)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.