Silverlon Wound Contact, Burn Contact Dressings

Dressing, Wound, Drug

Argentum Medical, LLC

The following data is part of a premarket notification filed by Argentum Medical, Llc with the FDA for Silverlon Wound Contact, Burn Contact Dressings.

Pre-market Notification Details

Device IDK190343
510k NumberK190343
Device Name:Silverlon Wound Contact, Burn Contact Dressings
ClassificationDressing, Wound, Drug
Applicant Argentum Medical, LLC 2571 Kaneville CT Geneva,  IL  60134
ContactAftab Ahmad
CorrespondentAftab Ahmad
Argentum Medical, LLC 2571 Kaneville CT Geneva,  IL  60134
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-02-14
Decision Date2019-07-18
Summary:summary

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