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View Full Version : Question on obtaining 510k submittal information on Class I sEMGDevices



unknown user
02-17-1999, 04:15 AM
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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