The key differences in 510k types - Traditional vs. Abbreviated vs. Special


Hi friends,

I would like to know the key difference in 510k type ( traditional vs abbreviated vs special).

My understanding says ;
Traditional - for new device (having a predicated device) and timeline is 90 days.
Special : For a device which is already and approved (OEM) and if made any modification but without changing to intended use, timeline 30 days.
Abbreviated : If any recognized standard specific to the type of your device you are submitting

Please provide your thought on the same.
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