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

    HUMAN TUBAL FLUID

    K Number: K953719 · Decision Nov 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    28
    Applicant Total
    4
    Review Days
    89

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    Basic Information

    Device Name
    HUMAN TUBAL FLUID
    K Number
    K953719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Technologies, Inc.
    Date Received
    August 9, 1995
    Decision Date
    November 6, 1995
    Product Code
    MFD
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MFD Cannula, Intrauterine Insemination

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    Other Clearances by Life Technologies, Inc.

    K Number Device Name
    K113566 OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
    DEN000008 DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
    K951835 MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE