Corpus ID: 36614528

Who owns the 510(k)?

@article{Donawa2008WhoOT,
  title={Who owns the 510(k)?},
  author={M. Donawa},
  journal={Medical device technology},
  year={2008},
  volume={19 2},
  pages={
          26, 28-9
        }
}
  • M. Donawa
  • Published 2008
  • Engineering, Medicine
  • Medical device technology
Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k). 

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