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FDA 510(k)

Unifine Pentips/ Unifine Pentips Plus

K-Number: K152339 · 2016-06-24

ApplicantOwen Mumford, Ltd.
Decision Date2016-06-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Unifine Pentips/ Unifine Pentips Plus is a medical device manufactured by Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2016-06-24 under approval number K152339. 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 Pentips/ Unifine Pentips Plus?

Unifine Pentips/ Unifine Pentips Plus is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Owen Mumford, Ltd.. The 510(k) number is K152339.

When was Unifine Pentips/ Unifine Pentips Plus approved by the FDA?

Unifine Pentips/ Unifine Pentips Plus received FDA 510(k) clearance on 2016-06-24, under approval number K152339.

What company makes Unifine Pentips/ Unifine Pentips Plus?

Unifine Pentips/ Unifine Pentips Plus is manufactured by Owen Mumford, Ltd..

What is the FDA product code for Unifine Pentips/ Unifine Pentips Plus?

The FDA product code for Unifine Pentips/ Unifine Pentips Plus 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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