List I. - Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data (to be submitted by July 26, 2004)
This article was originally published in The Gray Sheet
Executive Summary
List I. - Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data (to be submitted by July 26, 2004)