Schneider 510(k)
This article was originally published in The Gray Sheet
Executive Summary
Summary of safety and effectiveness data on the Wallstent tracheobronchial prosthesis, which gained 510(k) clearance for device modifications on June 2, is available from FDA. The agency's list of 510(k)s cleared under summary/statement requirements in June incorrectly indicated that the information would be made available by Schneider ("The Gray Sheet" July 18, p. 13)
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