Hydrofera Blue READY - Border

Dressing, Wound, Drug

Hydrofera, LLC

The following data is part of a premarket notification filed by Hydrofera, Llc with the FDA for Hydrofera Blue Ready - Border.

Pre-market Notification Details

Device IDK190268
501k NumberK190268
Device Name:Hydrofera Blue READY - Border
ClassificationDressing, Wound, Drug
Applicant Hydrofera, LLC 340 Progress Drive Manchester,  CT  06042
ContactSean Anderson
CorrespondentSean Anderson
Hydrofera, LLC 340 Progress Drive Manchester,  CT  06042
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-02-08
Decision Date2019-11-06

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