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FDA 510(k)

MicroDose Injector

K-Number: K203264 · 2021-04-26

ApplicantMedone Surgical, Inc.
Decision Date2021-04-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MicroDose Injector is a medical device manufactured by Medone Surgical, Inc.. It received FDA 510(k) clearance on 2021-04-26 under approval number K203264. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicroDose Injector?

MicroDose Injector is a medical device that received FDA 510(k) clearance on 2021-04-26. It is manufactured by Medone Surgical, Inc.. The 510(k) number is K203264.

When was MicroDose Injector approved by the FDA?

MicroDose Injector received FDA 510(k) clearance on 2021-04-26, under approval number K203264.

What company makes MicroDose Injector?

MicroDose Injector is manufactured by Medone Surgical, Inc..

What is the FDA product code for MicroDose Injector?

The FDA product code for MicroDose Injector is FMF.

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Official Source

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