FDA 510(k)

UNO 30

K-Number: K190028 · 2020-01-15

Decision Date2020-01-15

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

UNO 30 is a medical device manufactured by Genadyne Biotechnologies. It received FDA 510(k) clearance on 2020-01-15 under approval number K190028. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNO 30?

UNO 30 is a medical device that received FDA 510(k) clearance on 2020-01-15. It is manufactured by Genadyne Biotechnologies. The 510(k) number is K190028.

When was UNO 30 approved by the FDA?

UNO 30 received FDA 510(k) clearance on 2020-01-15, under approval number K190028.

What company makes UNO 30?

UNO 30 is manufactured by Genadyne Biotechnologies.

What is the FDA product code for UNO 30?

The FDA product code for UNO 30 is OMP.

Other Devices by Genadyne Biotechnologies

K182722XLR8 Abdominal Wound Dressing Kit

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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.