You can send an eSTAR or eCopy to submit your 510(k). After you submit your 510(k) to the FDA, and when the FDA receives the 510(k) submission, it assigns the … See more
Web ResultOct 4, 2022 · This step-by-step guide to preparing your 510 (k) submission aims to put the requirements in easy-to-understand terms and includes some helpful, actionable and practical tips you can begin to implement immediately.