Who owns the 510(k)?
نویسنده
چکیده
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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ورودعنوان ژورنال:
- Medical device technology
دوره 19 2 شماره
صفحات -
تاریخ انتشار 2008