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Question on obtaining 510k submittal information on Class I sEMGDevices

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  • Question on obtaining 510k submittal information on Class I sEMGDevices

    Hello my name is Richard Flores, and represent Noraxon U.S.A., Inc. I am the
    Production/Quality Control Engineer. We manufacturer Surface Electromyography
    equipment.
    I am requesting some information that I have been able to obtain for quite
    some time now. What I need is some information on where can I obtain data
    (e.g. books manuals etc..) on Guidelines on 510k submittal for FDA approval on
    Class I medical Devices. In particular Surface EMG.
    If possible examples of previously approved 510k's would help.

    We currently follow and practice Good Quality Systems requirements. What I
    need to do is begin to package together a 510k submittal application,and
    specification etc...Any help would be greatly appreciated.

    If possible CE requirements for the above listing is also on my list. Please
    advise.
    e-mail at FloresRch@aol.com

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