BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    INTRAUTERINE CATHETER

    K Number: K861305 · Decision Dec 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    28
    Applicant Total
    2
    Review Days
    248

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    Basic Information

    Device Name
    INTRAUTERINE CATHETER
    K Number
    K861305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Ram Development
    Date Received
    April 7, 1986
    Decision Date
    December 11, 1986
    Product Code
    HDR
    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
    HDR Cap, Cervical

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    Other Clearances by Ram Development

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