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

    NORSEN DEBRIDER

    K Number: K821801 · Decision Jul 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    43

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    Basic Information

    Device Name
    NORSEN DEBRIDER
    K Number
    K821801
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bel-Med, Inc.
    Date Received
    June 15, 1982
    Decision Date
    July 28, 1982
    Product Code
    GED
    Advisory Committee
    General, Plastic Surgery
    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
    GED Brush, Dermabrasion, Manual

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