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510(k) Data Aggregation
K Number
K141603Device Name
Ultra Silver Dressings
Manufacturer
MILLIKEN HEALTHCARE PRODUCTS, LLC
Date Cleared
2014-10-22
(128 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MILLIKEN HEALTHCARE PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
Device Description
The ULTRA Silver Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hot-melt adhesive and a layer of a silver-containing knitted composite fabric.
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K Number
K110715Device Name
INTERDRY SILVER
Manufacturer
MILLIKEN HEALTHCARE PRODUCTS, LLC
Date Cleared
2011-11-04
(234 days)
Product Code
FRL
Regulation Number
880.5300Why did this record match?
Applicant Name (Manufacturer) :
MILLIKEN HEALTHCARE PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterDry Textile is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile reduces microbial colonization in the fabric.
Device Description
InterDry is a non-sterile skin protectant fabric with an antimicrobial silver complex. InterDry is a single patient use product that is custom cut from a multiuse package.
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K Number
K103141Device Name
LOW ADHERENT AFM AG DRESSINGS
Manufacturer
MILLIKEN HEALTHCARE PRODUCTS, LLC
Date Cleared
2011-01-21
(88 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MILLIKEN HEALTHCARE PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
Device Description
The Low Adherent AFM Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are designed to contact the wound as a primary dressing and permit the passage of fluids. The dressings provide a protective environment for the wound and an effective protection against microbial contamination in the dressing. The devices are effective antimicrobial barrier dressings against both Gram-positive and Gram-negative bacteria, including the following organisms: methicillin-resistant Staphylococcus aureus (MRSA). methicillin- resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus faecalis (VRE), Pseudomonas aeruginosa, and Acinetobacter baumannii.
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