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

    ALLDRESS, ABSORBENT FILM DRESSING

    K Number: K983554 · Decision Nov 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    10
    Review Days
    28

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    Basic Information

    Device Name
    ALLDRESS, ABSORBENT FILM DRESSING
    K Number
    K983554
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Molnlycke Health Care, Inc.
    Date Received
    October 13, 1998
    Decision Date
    November 10, 1998
    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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