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

    O.B. TAMPONS

    K Number: K023789 · Decision Dec 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    6
    Review Days
    23

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    O.B. TAMPONS
    K Number
    K023789
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mcneil-Ppc, Inc.
    Date Received
    November 13, 2002
    Decision Date
    December 6, 2002
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HEB), ordered by most recent decision date.

    Livi Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Unscented menstrual three-piece applicator tampon

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SABA Tampons

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Mcneil-Ppc, Inc.

    K Number Device Name
    K081236 K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
    K072421 K-Y BRAND YOURS+MINE
    K072360 K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
    K062535 K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
    K053397 K-Y BRAND SENSUAL MIST