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

    STRAITH DRAIN INSERTER

    K Number: K840835 · Decision Apr 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    526
    Registration Numbers
    526
    Same Product Code
    18
    Applicant Total
    12
    Review Days
    59

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    Basic Information

    Device Name
    STRAITH DRAIN INSERTER
    K Number
    K840835
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgical Technology Laboratories, Inc.
    Date Received
    February 24, 1984
    Decision Date
    April 23, 1984
    Product Code
    FZX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZX Guide, Surgical, Instrument

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