Ortoma AB receives administrative acceptance review from FDA for Ortoma Treatment Solution™
FDA writes “An administrative acceptance review was conducted on your premarket notification (510(k)) K172515/S002, and it was found to contain all of the necessary elements and information needed to proceed with the substantive review.” “- It is an extensive work with the FDA application that now enters its final phase. An approval from FDA opens the big American market for Ortoma, says CEO Matts Andersson.” For further information, please contact: Prof. Gunnar Németh, MD, PhD, Chairman of the BoardMobile: +46 70-529 20 00e-mail: gunnar@nemeth.se About Ortoma AB (publ)