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

    SPACER

    K Number: K925870 · Decision May 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    181

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    Basic Information

    Device Name
    SPACER
    K Number
    K925870
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bip USA, Inc.
    Date Received
    November 19, 1992
    Decision Date
    May 19, 1993
    Product Code
    MJG
    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
    MJG Device, Percutaneous, Biopsy

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