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FDA 510(k)

PHantom Trilogy

K-Number: K213534 · 2022-03-11

Decision Date2022-03-11
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHantom Trilogy is a medical device manufactured by Resurgeonz, LLC. It received FDA 510(k) clearance on 2022-03-11 under approval number K213534. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHantom Trilogy?

PHantom Trilogy is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Resurgeonz, LLC. The 510(k) number is K213534.

When was PHantom Trilogy approved by the FDA?

PHantom Trilogy received FDA 510(k) clearance on 2022-03-11, under approval number K213534.

What company makes PHantom Trilogy?

PHantom Trilogy is manufactured by Resurgeonz, LLC.

What is the FDA product code for PHantom Trilogy?

The FDA product code for PHantom Trilogy is OLI.

Related Devices (Code: OLI)

Official Source

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