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

    DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH

    K Number: K913235 · Decision Oct 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    50
    Review Days
    101

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    Basic Information

    Device Name
    DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
    K Number
    K913235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Davol, Inc.
    Date Received
    July 22, 1991
    Decision Date
    October 31, 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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