Gish Anticipates 510(k) Submission For EZ Flow 480 By 1999
This article was originally published in The Gray Sheet
Executive Summary
Gish Biomedical hopes to file a 510(k) submission with FDA by January 1999 to cover modifications to its previously marketed EZ Flow 480 Ambulatory/Pole mounted infusion pump following the receipt of a March 3 warning letter from the agency.