FDA 510(k)

Voyant Fine Fusion

K-Number: K153017 · 2016-07-06

Decision Date2016-07-06

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Voyant Fine Fusion is a medical device manufactured by Applied Medical Resources. It received FDA 510(k) clearance on 2016-07-06 under approval number K153017. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voyant Fine Fusion?

Voyant Fine Fusion is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by Applied Medical Resources. The 510(k) number is K153017.

When was Voyant Fine Fusion approved by the FDA?

Voyant Fine Fusion received FDA 510(k) clearance on 2016-07-06, under approval number K153017.

What company makes Voyant Fine Fusion?

Voyant Fine Fusion is manufactured by Applied Medical Resources.

What is the FDA product code for Voyant Fine Fusion?

The FDA product code for Voyant Fine Fusion is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.