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510(k) Data Aggregation

    K Number
    K973538
    Device Name
    N-TERFACE
    Manufacturer
    WINFIELD LABORATORIES, INC.
    Date Cleared
    1997-12-16

    (89 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WINFIELD LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    N-TERFACE Interpositional Surfacing Material is indicated for use as a wound contact layer for partial thickness burns and and confection worselves of laser skin resurfacing. indicated for use as a wound concace in ......................................................................................................................................
    Device Description
    N-TERFACE® Interpositional Surfacing Material is an extruded, non-woven, high density polyethylene sheeting material with the following physical properties: Weight, oz/yd2: 0.36 to 0.8, Thickness, Mils: 4.0 to 5.0, Tensile, Ibs/in .: roll direction 14 to 77, cross direction 1.5 to 4.5, Air Permeability ft3/min/ft2: 545 to 1144.
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