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510(k) Data Aggregation

    K Number
    K212304
    Device Name
    Callaly Tampliner (super plus absorbency)
    Manufacturer
    Calla Lily Personal Care, Ltd.
    Date Cleared
    2021-08-19

    (27 days)

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

    Calla Lily Personal Care, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    Not Found
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    K Number
    K211469
    Device Name
    Callaly Tampliner
    Manufacturer
    Calla Lily Personal Care, Ltd.
    Date Cleared
    2021-06-10

    (30 days)

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

    Calla Lily Personal Care, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K201003
    Device Name
    Callaly Tampliner
    Manufacturer
    Calla Lily Personal Care, Ltd.
    Date Cleared
    2020-12-07

    (235 days)

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

    Calla Lily Personal Care, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

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