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

    I.V. STARR KIT

    K Number: K912161 · Decision Oct 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    24
    Applicant Total
    30
    Review Days
    145

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    Basic Information

    Device Name
    I.V. STARR KIT
    K Number
    K912161
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Device Inspection Co., Inc.
    Date Received
    May 16, 1991
    Decision Date
    October 8, 1991
    Product Code
    LKB
    Advisory Committee
    Unknown
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKB Pad, Alcohol, Device Disinfectant

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