BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE

    K Number: K063688 · Decision Jan 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    387
    Registration Numbers
    387
    Same Product Code
    75
    Applicant Total
    60
    Review Days
    35

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    Basic Information

    Device Name
    SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
    K Number
    K063688
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Anspach Effort, Inc.
    Date Received
    December 12, 2006
    Decision Date
    January 16, 2007
    Product Code
    HWE
    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
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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