Amsco
This article was originally published in The Gray Sheet
Executive Summary
Withdraws 510(k) submission for the VHP Series 100 Rigid Endoscope Sterilizer "due to a lack of assurance of the validity of data supporting the submission," the firm announces Nov. 16. Submitted in 1992, the 510(k) was reviewed during a recent FDA inspection. Amsco plans to submit a new 510(k) for the device in 1995