IODOFOAM IODOPHOR FOAM DRESSING

Dressing, Wound, Drug

PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Progressive Woundcare Technologies, Llc with the FDA for Iodofoam Iodophor Foam Dressing.

Pre-market Notification Details

Device IDK122634
510k NumberK122634
Device Name:IODOFOAM IODOPHOR FOAM DRESSING
ClassificationDressing, Wound, Drug
Applicant PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC 150 LEVINBERG LANE Wayne,  NJ  07470
ContactMason Diamond
CorrespondentMason Diamond
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC 150 LEVINBERG LANE Wayne,  NJ  07470
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-08-29
Decision Date2013-03-12
Summary:summary

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