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

    O.B. APPLICATOR TAMPONS, O.B. TAMPONS

    K Number: K991118 · Decision Jun 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    45
    Review Days
    89

    Basic Information

    Device Name
    O.B. APPLICATOR TAMPONS, O.B. TAMPONS
    K Number
    K991118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Personal Products Co.
    Date Received
    April 1, 1999
    Decision Date
    June 29, 1999
    Product Code
    HEB
    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
    HEB Tampon, Menstrual, Unscented

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