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How to Determine Substantial Equivalence for an FDA 510k

fda 510k substantial equivalence
An FDA 510(k) Premarket Notification is a document containing information required under 21 CFR 807 Subpart. It is based on the concept of substantial equivalence (SE) to a medical device legally marketed in the USA (or predicate device). An FDA 510(k) Premarket Notification...

Our Approach to the FDA 510(k) Premarket Notification Process

fda 510(k) premarket notification
To obtain 510k approval from the FDA we have determined that the following approach is the most efficient and cost effective for our clients, since it dramatically increases the probability of a successful FDA 510k submission. The first step to ensure a successful FDA 510(k)...

FDA 510(k) Clearance Consulting for Medical Devices and IVD’s

fda 510k consulting
  As FDA 510k consultants we can file an FDA 510(k) submission for your Class II medical device or IVD (In Vitro Diagnostics) with the Food and Drug Administration. What is an FDA 510k? A 510(k) is a premarket notification submission made to FDA to demonstrate that the...