Clarification: 510k is premarket notification; it provides no patent or FDA approval.

@article{Burkhart2008Clarification5I,
  title={Clarification: 510k is premarket notification; it provides no patent or FDA approval.},
  author={Craig Nathaniel Burkhart},
  journal={Journal of drugs in dermatology : JDD},
  year={2008},
  volume={7 2},
  pages={105}
}