BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MIDAS GOLD ELECTROFORMING SYSTEM

    K Number: K955509 · Decision Dec 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    626
    Applicant Total
    10
    Review Days
    24

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    Basic Information

    Device Name
    MIDAS GOLD ELECTROFORMING SYSTEM
    K Number
    K955509
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Austenal, Inc.
    Date Received
    December 4, 1995
    Decision Date
    December 28, 1995
    Product Code
    EJT
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EJT Alloy, Gold-Based Noble Metal

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