The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] – Guidance for Industry and Food and Drug Administration Staff (PDF By Effective Medicine On July 25, 2014 In Medical Devices Tagged medical devices facebook tweet google+ %PDF-1.6% 2211 0 objstream hÞ¬[ÛŽ~0v9vbCÒ›0e8QB9E6z80nX,1e$.%KUby?,Z!deb]H+fÞ¢p