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

    PEDI VAGINAL ASPIRATOR

    K Number: K954903 · Decision Apr 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    104
    Review Days
    187

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    Basic Information

    Device Name
    PEDI VAGINAL ASPIRATOR
    K Number
    K954903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1050
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Urological, Inc.
    Date Received
    October 25, 1995
    Decision Date
    April 29, 1996
    Product Code
    HFC
    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
    HFC Aspirator, Endocervical

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