BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    Cohitech Reusable Tampon Applicator

    K Number: K212479 · Decision Oct 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    7
    Review Days
    60

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    Basic Information

    Device Name
    Cohitech Reusable Tampon Applicator
    K Number
    K212479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cotton High Tech S.L.
    Date Received
    August 9, 2021
    Decision Date
    October 8, 2021
    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 Cotton High Tech S.L.

    K Number Device Name
    K252939 COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
    K220238 Cohitech Cottonlock Tampons with Reusable Applicator
    K211775 Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
    K182813 COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
    K152284 COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
    K091084 MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS