NovoSorb Matrix

Dressing, Wound, Drug

PolyNovo Biomaterials Pty Ltd

The following data is part of a premarket notification filed by Polynovo Biomaterials Pty Ltd with the FDA for Novosorb Matrix.

Pre-market Notification Details

Device IDK221686
510k NumberK221686
Device Name:NovoSorb Matrix
ClassificationDressing, Wound, Drug
Applicant PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne,  AU 3207
ContactTarun Nekkenti
CorrespondentTarun Nekkenti
PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne,  AU 3207
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-10
Decision Date2022-09-15

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