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

    Interlude Rolled Tampons in Plastic Applicator

    K Number: K191431 · Decision Oct 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    3
    Review Days
    131

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    Basic Information

    Device Name
    Interlude Rolled Tampons in Plastic Applicator
    K Number
    K191431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Albaad Fem
    Date Received
    May 29, 2019
    Decision Date
    October 7, 2019
    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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    Other Clearances by Albaad Fem

    K Number Device Name
    K181911 Interlude 100% Cotton Tampon
    K173225 Interlude and private label Unscented 3-piece compact applicator tampon