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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Official Source
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