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

    REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES

    K Number: K012536 · Decision Nov 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    64
    Review Days
    87

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    Basic Information

    Device Name
    REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
    K Number
    K012536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sterilmed, Inc.
    Date Received
    August 7, 2001
    Decision Date
    November 2, 2001
    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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