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510(k) Data Aggregation

    K Number
    K182814
    Device Name
    Rael Tampon
    Manufacturer
    Rael, Inc.
    Date Cleared
    2019-07-15

    (285 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rael, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rael Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
    Device Description
    Rael Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
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