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

    PNEUMOTHORAX KIT, MODIFICATION

    K Number: K904021 · Decision Oct 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    28
    Applicant Total
    110
    Review Days
    41

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    Basic Information

    Device Name
    PNEUMOTHORAX KIT, MODIFICATION
    K Number
    K904021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3150
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Arrow Intl., Inc.
    Date Received
    August 29, 1990
    Decision Date
    October 9, 1990
    Product Code
    JDC
    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
    JDC Prosthesis, Elbow, Constrained, Cemented

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