BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING

    K Number: K990438 · Decision Mar 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    9
    Review Days
    42

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    Basic Information

    Device Name
    DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
    K Number
    K990438
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dermaphylyx, Inc.
    Date Received
    February 11, 1999
    Decision Date
    March 25, 1999
    Product Code
    MGP
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGP Dressing, Wound And Burn, Occlusive

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    Other Clearances by Dermaphylyx, Inc.

    K Number Device Name
    K992302 DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
    K991920 DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
    K991933 DERMAPHYLYX FOAM ISLAND DRESSING
    K991609 DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
    K991608 DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
    K991061 DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
    K990875 DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
    K990891 DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING