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FDA 510(k)

PreferX Delivery System

K-Number: K210997 · 2021-09-07

ApplicantMd3, LLC
Decision Date2021-09-07
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PreferX Delivery System is a medical device manufactured by Md3, LLC. It received FDA 510(k) clearance on 2021-09-07 under approval number K210997. 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 PreferX Delivery System?

PreferX Delivery System is a medical device that received FDA 510(k) clearance on 2021-09-07. It is manufactured by Md3, LLC. The 510(k) number is K210997.

When was PreferX Delivery System approved by the FDA?

PreferX Delivery System received FDA 510(k) clearance on 2021-09-07, under approval number K210997.

What company makes PreferX Delivery System?

PreferX Delivery System is manufactured by Md3, LLC.

What is the FDA product code for PreferX Delivery System?

The FDA product code for PreferX Delivery System is FMF.

Related Clinical Trials

Related Devices (Code: FMF)

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.