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

    BOSTON INFUSION SETS

    K Number: K822408 · Decision Sep 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    5
    Review Days
    51

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    Basic Information

    Device Name
    BOSTON INFUSION SETS
    K Number
    K822408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    The Boston Medical Group
    Date Received
    August 10, 1982
    Decision Date
    September 30, 1982
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by The Boston Medical Group

    K Number Device Name
    K822406 BOSTON SOLUTION INFUSION SETS
    K822410 BOSTON BLOOD DONOR SETS
    K822409 BOSTON BLOOD TRANSFUSION SETS
    K822407 BOSTON SCALP VEIN INFUSION SETS