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

    CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM

    K Number: K902401 · Decision Oct 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    9
    Review Days
    496

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    Basic Information

    Device Name
    CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
    K Number
    K902401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Burron Medical, Inc.
    Date Received
    May 30, 1990
    Decision Date
    October 8, 1991
    Product Code
    FMF
    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
    FMF Syringe, Piston

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