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FDA 510(k)

Miromatrix Biological Mesh

K-Number: K160400 · 2016-06-08

Decision Date2016-06-08
Product CodeOXH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Miromatrix Biological Mesh is a medical device manufactured by Miromatrix Medical, Inc.. It received FDA 510(k) clearance on 2016-06-08 under approval number K160400. The device is classified under product code OXH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miromatrix Biological Mesh?

Miromatrix Biological Mesh is a medical device that received FDA 510(k) clearance on 2016-06-08. It is manufactured by Miromatrix Medical, Inc.. The 510(k) number is K160400.

When was Miromatrix Biological Mesh approved by the FDA?

Miromatrix Biological Mesh received FDA 510(k) clearance on 2016-06-08, under approval number K160400.

What company makes Miromatrix Biological Mesh?

Miromatrix Biological Mesh is manufactured by Miromatrix Medical, Inc..

What is the FDA product code for Miromatrix Biological Mesh?

The FDA product code for Miromatrix Biological Mesh is OXH.

Other Devices by Miromatrix Medical, Inc.

Related Devices (Code: OXH)

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.