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 IDK181330
510k NumberK181330
Device Name:NeoMatriX Wound Matrix
ClassificationDressing, Wound, Collagen
Applicant NeXtGen Biologics, Inc. 747 SW 2nd Ave - IMB 5 Gainesville,  FL  32601
ContactJonelle L. Toothman
CorrespondentJanice Hogan
Hogan Lovells US 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 Received2018-05-18
Decision Date2018-10-11
Summary:summary

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