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FDA 510(k)

SNUCONE Tissue Level Implant System

K-Number: K222792 · 2023-06-08

Decision Date2023-06-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SNUCONE Tissue Level Implant System is a medical device manufactured by Snucone Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under approval number K222792. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SNUCONE Tissue Level Implant System?

SNUCONE Tissue Level Implant System is a medical device that received FDA 510(k) clearance on 2023-06-08. It is manufactured by Snucone Co., Ltd.. The 510(k) number is K222792.

When was SNUCONE Tissue Level Implant System approved by the FDA?

SNUCONE Tissue Level Implant System received FDA 510(k) clearance on 2023-06-08, under approval number K222792.

What company makes SNUCONE Tissue Level Implant System?

SNUCONE Tissue Level Implant System is manufactured by Snucone Co., Ltd..

What is the FDA product code for SNUCONE Tissue Level Implant System?

The FDA product code for SNUCONE Tissue Level Implant System is DZE.

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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.