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

    ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011

    K Number: K940179 · Decision May 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    669
    Applicant Total
    142
    Review Days
    496

    Basic Information

    Device Name
    ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
    K Number
    K940179
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Received
    January 12, 1994
    Decision Date
    May 23, 1995
    Product Code
    HRX
    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
    HRX Arthroscope

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