BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HEMATASTAT C-70B

    K Number: K913128 · Decision Sep 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    136

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    Basic Information

    Device Name
    HEMATASTAT C-70B
    K Number
    K913128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Separation Technology, Inc.
    Date Received
    May 10, 1991
    Decision Date
    September 23, 1991
    Product Code
    GKG
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GKG Centrifuge, Hematocrit

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    Other Clearances by Separation Technology, Inc.

    K Number Device Name
    K890849 HEMATASTAT H-70