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

    PROBET (TM)

    K Number: K903002 · Decision Apr 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    PROBET (TM)
    K Number
    K903002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1060
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Gynopharma, Inc.
    Date Received
    July 9, 1990
    Decision Date
    April 5, 1991
    Product Code
    HFF
    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
    HFF Aspirator, Endometrial

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    Other Clearances by Gynopharma, Inc.

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