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510(k) Data Aggregation
K Number
K961662Device Name
ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
Manufacturer
Date Cleared
1996-06-13
(44 days)
Product Code
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
MARINER BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is intended for use in the local management of surgical incisions, trauma inflicted wounds, abrasions, superficial burns, secondary dressing for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect skin from potential irritation, maceration, and to manage exudate.
Device Description
The ADVANCED CARETM Hydrophilic Wound Dressings will be manufactured from hydrophilic polyurethane foam in various thicknesses and configurations in sizes up to 25" by 25" squares, and thicknesses from 100 mil to 0.05".
The dressings will be offered as sterile stand alone polyurethane dressings individually packaged.
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