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

    AMERICAN BURN SHEET

    K Number: K922143 · Decision Aug 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    64
    Applicant Total
    14
    Review Days
    96

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    Basic Information

    Device Name
    AMERICAN BURN SHEET
    K Number
    K922143
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6060
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Silk Sutures, Inc.
    Date Received
    May 6, 1992
    Decision Date
    August 10, 1992
    Product Code
    KME
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KME Bedding, Disposable, Medical

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