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FDA 510(k)

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G

K-Number: K173881 · 2018-07-11

ApplicantOwen Mumford, Ltd.
Decision Date2018-07-11
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G is a medical device manufactured by Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2018-07-11 under approval number K173881. 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 5mm x 30G, Unifine SafeControl 8mm x 30G?

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G is a medical device that received FDA 510(k) clearance on 2018-07-11. It is manufactured by Owen Mumford, Ltd.. The 510(k) number is K173881.

When was Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G approved by the FDA?

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G received FDA 510(k) clearance on 2018-07-11, under approval number K173881.

What company makes Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G?

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G is manufactured by Owen Mumford, Ltd..

What is the FDA product code for Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G?

The FDA product code for Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G is FMI.

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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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