Zdrowie i gospodarka · 10/07/1997
Medispec, Ltd.; Premarket Approval of EconolithSUPTM/SUP Extracorporeal Shock Wave Lithotripter
The Food and Drug Administration (FDA) is announcing its approval of the application by Medispec Ltd., Rockville, MD, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Medispec Ltd., Econolith TM Lithotripter. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of April 7, 1997, of the approval of the application.