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510(k) Data Aggregation
K Number
K130553Device Name
ABSOCLEAR
Manufacturer
Date Cleared
2013-07-03
(121 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PHARMAPLAST S.A.E.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sterile, single-use dressings for management of pressure ulcers, 1st and 2nd degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.
Device Description
The AbsoClear product family is a series of single-use, sterile transparent synthetic wound dressings made of absorbent acrylic polymers. The dressings maintain a moist wound environment, which has been shown to be conducive to wound healing, but that also can also absorb wound exudate. Full transparency allows monitoring wound healing stages without removal of the dressing. The sterile dressings are supplied singly in sealed trilaminate pouches and are sterilized by gamma irradiation.
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