510k Submission | Integrated Assessment Services (IAS)

What is 510k Submission?
Medical device manufacturers utilize a premarket notice (also known as a "premarket submission" or "510k") to show the FDA that their device is substantially identical (as a "predicate" or "reference") to another lawfully marketed item currently on the market. This makes it easier and faster for your firm to obtain its medical devices approved by requiring far less clinical trial evidence.
Integrated Assessment Services (IAS) assists firms in submitting a 510k premarket notice to the US Food and Drug Administration (US FDA). The 510k submission process provides a way for medical device manufacturers to easily sell their products in the USA. For more information about our 510k Submission services, please visit: www.iascertifi...
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Is 510k documents needed for ultrasonic dental tartar removal machine?