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510(k) Data Aggregation

    K Number
    K240708
    Device Name
    Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
    Manufacturer
    Suzhou Borage Medical Technology Co., Ltd.
    Date Cleared
    2024-05-10

    (56 days)

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

    Suzhou Borage Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Organic Cotton Tampon and Organic Cotton PESCV cord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
    Device Description
    Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are traditional unscented menstrual tampons. They share the same design and raw materials except the material of the removal strings. Each of them are available in two configurations (i.e., digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. Both of Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are provided in 4 absorbency: light (≤6g), regular (6-9g), super (9-12g) and super plus (12-15g). Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.
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    K Number
    K222046
    Device Name
    Unscented Menstrual Tampon
    Manufacturer
    Suzhou Borage Medical Technology Co., Ltd.
    Date Cleared
    2022-09-30

    (81 days)

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

    Suzhou Borage Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The unscented menstrual tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
    Device Description
    The proposed device is a traditional unscented menstrual tampon, and it has two types (i.e. digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by overwap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The proposed device is provided in 4 absorbencies: light (≤6g), regular (6~9g), super (9~12g) and super plus (12~15g). Each device is individually wrapped and packaged in sealed multi-unit containers for retail sale. And it is provided non-sterile and for single use only.
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