BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇹🇼 Taiwan

    AnsCare ChitoClot Pad

    K Number: K150963 · Decision Nov 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    4
    Review Days
    209

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    Basic Information

    Device Name
    AnsCare ChitoClot Pad
    K Number
    K150963
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Benq Materials Corporation
    Date Received
    April 10, 2015
    Decision Date
    November 5, 2015
    Product Code
    QSY
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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    Other Clearances by Benq Materials Corporation

    K Number Device Name
    K242056 miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
    K193185 Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
    K143462 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)