BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    THE DE SOUTTER M193 REAMER

    K Number: K930784 · Decision Oct 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    253

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    Basic Information

    Device Name
    THE DE SOUTTER M193 REAMER
    K Number
    K930784
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    De Soutter Medical, Ltd.
    Date Received
    February 16, 1993
    Decision Date
    October 27, 1993
    Product Code
    HSZ
    Advisory Committee
    General, Plastic Surgery
    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
    HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

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