FDA 510(k)

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

K-Number: K173881 · 2018-07-11

Decision Date2018-07-11

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2018-07-11 under 510(k) 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. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K173881.

When did Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G receive FDA 510(k) clearance?

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

Who is the listed applicant for Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G?

The FDA 510(k) record lists Owen Mumford, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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.