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510(k) K211972

Omeza Collagen Matrix by Omeza, LLC — Product Code FRO

K211972 is an FDA 510(k) premarket notification submitted by Omeza, LLC for the device "Omeza Collagen Matrix". The FDA issued a decision of Substantially Equivalent on September 1, 2021. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2021
Date Received
June 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources