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FDA 510(k)

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

K-Number: K153041 · 2016-03-14

Decision Date2016-03-14
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-03-14 under approval number K153041. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is a medical device that received FDA 510(k) clearance on 2016-03-14. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K153041.

When was Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling approved by the FDA?

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling received FDA 510(k) clearance on 2016-03-14, under approval number K153041.

What company makes Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

The FDA product code for Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is JXG.

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Official Source

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