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

    BLOOD ADMINISTRATION SET

    K Number: K920788 · Decision Jun 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    29
    Applicant Total
    19
    Review Days
    105

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    Basic Information

    Device Name
    BLOOD ADMINISTRATION SET
    K Number
    K920788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Douglas Medical Products Corp.
    Date Received
    February 20, 1992
    Decision Date
    June 4, 1992
    Product Code
    BRZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BRZ Set, Blood Transfusion

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    Other Clearances by Douglas Medical Products Corp.

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    K942101 4-LEAD IRRIGATION SET
    K941453 CHECK VALVE SOLUTION SET
    K930854 SOLUTION SET WITH .2 MICRON FILTER
    K932637 SUBCUTANEOUS INFUSION SET
    K931659 3 LEAD CONNECTOR
    K931658 IN-LINE BURETTE SET
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