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

    K ORTHOPEDIC TABLE

    K Number: K881101 · Decision Apr 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    K ORTHOPEDIC TABLE
    K Number
    K881101
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Specialties, Inc.
    Date Received
    March 15, 1988
    Decision Date
    April 6, 1988
    Product Code
    JEB
    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
    JEB Table, Surgical With Orthopedic Accessories, Manual

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