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Process of FDA 510k Submission – i3cglobal The consultant or the consulting team should have through knowledge and previous experiences in Medical Device submissions to FDA. Prepare 510k notification with the help of a consultant, and submit to FDA directly or through UL / Interk / BSI with the help of Consultant / US Agent. Once the establishment registration is done, the products intended to sell in US has to list under registered establishments. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number. http://www.i3cglobal.com/medical-device/us-fda/process-of-510k-registration.html
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http://www.i3cglobal.com/medical-device/us-fda/process-of-510k-registration.html For More Details Logon To Phone no.- +91 80 5064 8432 E-Mail: enquiry@i3cglobal.com