BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING

    K Number: K991609 · Decision Jul 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    9
    Review Days
    71

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    Basic Information

    Device Name
    DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
    K Number
    K991609
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dermaphylyx, Inc.
    Date Received
    May 10, 1999
    Decision Date
    July 20, 1999
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

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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
    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
    K990438 DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING