FDA 510(k)

Safe Block Pen Needle

K-Number: K151311 · 2016-02-10

Decision Date2016-02-10

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Safe Block Pen Needle is a medical device manufactured by Artsana S.P.A. It received FDA 510(k) clearance on 2016-02-10 under approval number K151311. 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 Safe Block Pen Needle?

Safe Block Pen Needle is a medical device that received FDA 510(k) clearance on 2016-02-10. It is manufactured by Artsana S.P.A. The 510(k) number is K151311.

When was Safe Block Pen Needle approved by the FDA?

Safe Block Pen Needle received FDA 510(k) clearance on 2016-02-10, under approval number K151311.

What company makes Safe Block Pen Needle?

Safe Block Pen Needle is manufactured by Artsana S.P.A.

What is the FDA product code for Safe Block Pen Needle?

The FDA product code for Safe Block Pen Needle is FMI.

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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.