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FDA 510(k)

NavaClick Injection System

K-Number: K231877 · 2023-11-30

ApplicantLineage Biomedical, Inc.
Decision Date2023-11-30
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NavaClick Injection System is a medical device manufactured by Lineage Biomedical, Inc.. It received FDA 510(k) clearance on 2023-11-30 under approval number K231877. 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 NavaClick Injection System?

NavaClick Injection System is a medical device that received FDA 510(k) clearance on 2023-11-30. It is manufactured by Lineage Biomedical, Inc.. The 510(k) number is K231877.

When was NavaClick Injection System approved by the FDA?

NavaClick Injection System received FDA 510(k) clearance on 2023-11-30, under approval number K231877.

What company makes NavaClick Injection System?

NavaClick Injection System is manufactured by Lineage Biomedical, Inc..

What is the FDA product code for NavaClick Injection System?

The FDA product code for NavaClick Injection System is FMF.

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Official Source

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