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

    REGNELL HYDRAULIC FEMORAL PROTHESIS

    K Number: K830285 · Decision Mar 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    41

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    Basic Information

    Device Name
    REGNELL HYDRAULIC FEMORAL PROTHESIS
    K Number
    K830285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Besco Financial Service
    Date Received
    January 27, 1983
    Decision Date
    March 9, 1983
    Product Code
    KFX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External

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