Omeza Collagen Matrix

Dressing, Wound, Drug

Omeza, LLC

The following data is part of a premarket notification filed by Omeza, Llc with the FDA for Omeza Collagen Matrix.

Pre-market Notification Details

Device IDK211972
510k NumberK211972
Device Name:Omeza Collagen Matrix
ClassificationDressing, Wound, Drug
Applicant Omeza, LLC 25 South Osprey Avenue Sarasota,  FL  34236
ContactThomas Gardner
CorrespondentRandy Prebula
Hogan Lovells US LLP 555 13th Street NW Washington,  DC  20004
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-06-24
Decision Date2021-09-01

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