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

    OVAL SHAPES

    K Number: K973385 · Decision Dec 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    OVAL SHAPES
    K Number
    K973385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3025
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Technical Products, Inc.
    Date Received
    September 8, 1997
    Decision Date
    December 5, 1997
    Product Code
    HXA
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HXA Prosthesis, Tendon, Passive

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