FDA 510(k)

meso-relle (AAL34, AAL36, AM30G)

K-Number: K161255 · 2017-01-19

Decision Date2017-01-19

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

meso-relle (AAL34, AAL36, AM30G) is a medical device manufactured by Biotekne Srl. It received FDA 510(k) clearance on 2017-01-19 under approval number K161255. 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 meso-relle (AAL34, AAL36, AM30G)?

meso-relle (AAL34, AAL36, AM30G) is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Biotekne Srl. The 510(k) number is K161255.

When was meso-relle (AAL34, AAL36, AM30G) approved by the FDA?

meso-relle (AAL34, AAL36, AM30G) received FDA 510(k) clearance on 2017-01-19, under approval number K161255.

What company makes meso-relle (AAL34, AAL36, AM30G)?

meso-relle (AAL34, AAL36, AM30G) is manufactured by Biotekne Srl.

What is the FDA product code for meso-relle (AAL34, AAL36, AM30G)?

The FDA product code for meso-relle (AAL34, AAL36, AM30G) 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.