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

    DISPOSABLE CORONARY CONTROL SYRINGE

    K Number: K902346 · Decision Jun 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    32
    Review Days
    32

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    Basic Information

    Device Name
    DISPOSABLE CORONARY CONTROL SYRINGE
    K Number
    K902346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Advance Medical Designs, Inc.
    Date Received
    May 25, 1990
    Decision Date
    June 26, 1990
    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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