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510(k) Data Aggregation

    K Number
    K972336
    Device Name
    DERMAMEND HYDROGEL GAUZE DRESSING
    Manufacturer
    Date Cleared
    1997-07-29

    (36 days)

    Product Code
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMARX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To absorb exudate and to create and maintain a moist environment for partial and full thickness wounds including pressure ulcers, stage I-V; stasis ulers; dermal wounds; 1ª and 2ª degree burns; cuts, abrasions, and other imitations of the skin.
    Device Description
    DermaMend™ Hydrogel Gauze Dressing
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    K Number
    K970600
    Device Name
    DERMAMEND FOAM ISLAND DRESSING
    Manufacturer
    Date Cleared
    1997-05-08

    (79 days)

    Product Code
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMARX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K962089
    Device Name
    DERMAMEND GEL
    Manufacturer
    Date Cleared
    1996-11-05

    (160 days)

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

    DERMARX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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