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

    ABSORB FURN SHEET

    K Number: K820994 · Decision May 13, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    16
    Applicant Total
    19
    Review Days
    35

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    Basic Information

    Device Name
    ABSORB FURN SHEET
    K Number
    K820994
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5180
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    April 8, 1982
    Decision Date
    May 13, 1982
    Product Code
    FPY
    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
    FPY Sheet, Burn

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