SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING

Dressing, Wound, Drug

ARGENTUM MEDICAL

The following data is part of a premarket notification filed by Argentum Medical with the FDA for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing.

Pre-market Notification Details

Device IDK143001
510k NumberK143001
Device Name:SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
ClassificationDressing, Wound, Drug
Applicant ARGENTUM MEDICAL 2571 KANEVILLE COURT Geneva,  IL  60134
ContactC. Richard Foster
CorrespondentC Richard Foster
ARGENTUM MEDICAL 2571 KANEVILLE COURT Geneva,  IL  60134
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2014-10-17
Decision Date2014-11-07
Summary:summary

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