FDA-EVALUATING Complete Document History
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff

Complete Current Edition:
   2014 EDITION - Guidance for Industry and Food and Drug Administration Staff - July 28, 2014

Obsolete Revision Information:
   2011 DRAFT - Draft Guidance for Industry and Food and Drug Administration - Dec. 27, 2011