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    K Number
    K954982
    Device Name
    KSEA SCALP BLOOD COLLECTION SET
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-07-17

    (260 days)

    Product Code
    HGK
    Regulation Number
    884.1660
    Why did this record match?
    Product Code :

    HGK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KSEA Scalp Blood Collection Set is intended to to draw blood from the fetal scalp during obstetric endoscopic procedures.
    Device Description
    The KSEA Scalp Blood Collection Set is a manually operated, reusable surgical device consisting of handle, blade holder and tubing. The instrument is long enough to gain access to the surgical area and is designed to be used as an accessory to an endoscope. The body contact materials are surgical grade stainless steel and medical grade PVC.
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