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510(k) Data Aggregation
K Number
K073019Device Name
SILVERMED ANTIMICROBIAL SILVER HYDROGEL
Manufacturer
ARGENTIS BIOMEDICAL INCORPORATED
Date Cleared
2008-09-16
(327 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ARGENTIS BIOMEDICAL INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SilverMed™ Antimicrobial Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Device Description
The Argentis SilverMedIM Antimicrobial Hydrogel is a moist hydrogel dressing designed to deliver antimicrobial silver that inhibits the growth of microbial contaminants. The high moisture content gel absorbs destructive components of wound exudate while promoting healthy tissue healing. Stabilizers prevent discoloration and staining from the dressing. The product is available in 1.5 oz and 3 oz containers.
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