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

    PAN-AM MYELOGRAM TRAY

    K Number: K801431 · Decision Aug 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    16
    Review Days
    55

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    Basic Information

    Device Name
    PAN-AM MYELOGRAM TRAY
    K Number
    K801431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Waters Assoc., Inc.
    Date Received
    June 18, 1980
    Decision Date
    August 12, 1980
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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