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

    RECONSTITUTION ACCESSOREIS

    K Number: K950861 · Decision May 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    41
    Review Days
    88

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    Basic Information

    Device Name
    RECONSTITUTION ACCESSOREIS
    K Number
    K950861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Organon, Inc.
    Date Received
    February 27, 1995
    Decision Date
    May 26, 1995
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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