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FDA 510(k)

Unifine SafeControl

K-Number: K210399 · 2021-09-17

ApplicantOwen Mumford, Ltd.
Decision Date2021-09-17
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Unifine SafeControl is a medical device manufactured by Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2021-09-17 under approval number K210399. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unifine SafeControl?

Unifine SafeControl is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Owen Mumford, Ltd.. The 510(k) number is K210399.

When was Unifine SafeControl approved by the FDA?

Unifine SafeControl received FDA 510(k) clearance on 2021-09-17, under approval number K210399.

What company makes Unifine SafeControl?

Unifine SafeControl is manufactured by Owen Mumford, Ltd..

What is the FDA product code for Unifine SafeControl?

The FDA product code for Unifine SafeControl is FMI.

Other Devices by Owen Mumford, Ltd.

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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.

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