NeoMatriX Wound Matrix

Dressing, Wound, Collagen

NeXtGen Biologics, Inc.

The following data is part of a premarket notification filed by Nextgen Biologics, Inc. with the FDA for Neomatrix Wound Matrix.

Pre-market Notification Details

Device IDK210024
510k NumberK210024
Device Name:NeoMatriX Wound Matrix
ClassificationDressing, Wound, Collagen
Applicant NeXtGen Biologics, Inc. 13709 Progress Blvd Box11 Alachua,  FL  32615
ContactJonelle L. Toothman
CorrespondentJanice Hogan
Hogan Lovells LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-10-07

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