SiOxD Hemostatic Wound Matrix

Dressing, Wound, Drug

SiOxMed, LLC.

The following data is part of a premarket notification filed by Sioxmed, Llc. with the FDA for Sioxd Hemostatic Wound Matrix.

Pre-market Notification Details

Device IDK222189
510k NumberK222189
Device Name:SiOxD Hemostatic Wound Matrix
ClassificationDressing, Wound, Drug
Applicant SiOxMed, LLC. 2011 Muddy Creek Road Clemmons,  NC  27012
ContactMitch Dellinger
CorrespondentLinda Braddon
Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-22
Decision Date2022-11-18

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