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

    BARD HYSTERO-FLO II PUMP

    K Number: K933384 · Decision Dec 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    55
    Applicant Total
    24
    Review Days
    536

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    Basic Information

    Device Name
    BARD HYSTERO-FLO II PUMP
    K Number
    K933384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Davol Inc., Sub. C. R. Bard, Inc.
    Date Received
    July 12, 1993
    Decision Date
    December 30, 1994
    Product Code
    HIG
    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
    HIG Insufflator, Hysteroscopic

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