Episurf Medical provides update on 510(k) application
Episurf Medical (NASDAQ: EPIS B) today announces a status update on the previously communicated 510(k) application to the US FDA for US market clearance for the Episealer® Patellofemoral System. The present submission was filed in April this year and feedback from the substantive review has been received. The company has since been working interactively with the FDA to clarify ambiguities and provide complimentary documentation. There are planned activities to be performed during the autumn to close the remaining questions and take the review process to the final phase. “We are on a good