SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV

Negative Pressure Wound Therapy Powered Suction Pump

ARGENTUM MEDICAL, LLC

The following data is part of a premarket notification filed by Argentum Medical, Llc with the FDA for Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy Ag Antimicrobial Wound Contact Negativ.

Pre-market Notification Details

Device IDK141033
510k NumberK141033
Device Name:SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant ARGENTUM MEDICAL, LLC 2571 KANEVILLE COURT Geneva,  IL  60134
ContactC. Richard Foster
CorrespondentC. Richard Foster
ARGENTUM MEDICAL, LLC 2571 KANEVILLE COURT Geneva,  IL  60134
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2014-04-22
Decision Date2014-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857278000849 K141033 000
10857278000129 K141033 000
10857278000136 K141033 000
00857278000146 K141033 000
00857278000153 K141033 000
00857278000160 K141033 000
10857278000174 K141033 000
10857278000181 K141033 000
20857278000621 K141033 000
10857278000808 K141033 000
10857278000815 K141033 000
10857278000822 K141033 000
10857278000839 K141033 000
00857278000115 K141033 000

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