BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    CLO-SURPLUSP.A.D.

    K Number: K032986 · Decision Mar 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    4
    Review Days
    159

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    Basic Information

    Device Name
    CLO-SURPLUSP.A.D.
    K Number
    K032986
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scion Cardio-Vascular, Inc.
    Date Received
    September 24, 2003
    Decision Date
    March 1, 2004
    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 Scion Cardio-Vascular, Inc.

    K Number Device Name
    K112961 CLO-SURPLUS P.A.D.
    K092552 CLO-SURPLUS P.A.D.
    K052509 M-BOLUS EMBOLIC MICROSPHERES