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FDA 510(k)

Transit-Pellets

K-Number: K222000 · 2023-01-18

ApplicantMedifactia AB
Decision Date2023-01-18
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Transit-Pellets is a medical device manufactured by Medifactia AB. It received FDA 510(k) clearance on 2023-01-18 under approval number K222000. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transit-Pellets?

Transit-Pellets is a medical device that received FDA 510(k) clearance on 2023-01-18. It is manufactured by Medifactia AB. The 510(k) number is K222000.

When was Transit-Pellets approved by the FDA?

Transit-Pellets received FDA 510(k) clearance on 2023-01-18, under approval number K222000.

What company makes Transit-Pellets?

Transit-Pellets is manufactured by Medifactia AB.

What is the FDA product code for Transit-Pellets?

The FDA product code for Transit-Pellets is FFX.

Other Devices by Medifactia AB

Related Devices (Code: FFX)

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.