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FDA 510(k)

Omeza Collagen Matrix

K-Number: K211972 · 2021-09-01

ApplicantOmeza, LLC
Decision Date2021-09-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Omeza Collagen Matrix is a medical device manufactured by Omeza, LLC. It received FDA 510(k) clearance on 2021-09-01 under approval number K211972. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omeza Collagen Matrix?

Omeza Collagen Matrix is a medical device that received FDA 510(k) clearance on 2021-09-01. It is manufactured by Omeza, LLC. The 510(k) number is K211972.

When was Omeza Collagen Matrix approved by the FDA?

Omeza Collagen Matrix received FDA 510(k) clearance on 2021-09-01, under approval number K211972.

What company makes Omeza Collagen Matrix?

Omeza Collagen Matrix is manufactured by Omeza, LLC.

What is the FDA product code for Omeza Collagen Matrix?

The FDA product code for Omeza Collagen Matrix is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT05081284 Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix ACTIVE_NOT_RECRUITING NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT07219316 Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision COMPLETED

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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.

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