ISOplan USA
Phone: 386-868-0618
E-mail: isoplan@fda-510k.com

Category

substantial equivalence

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...
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