Bioetica, Inc.; Premarket Approval of HEMOSTAGENERegister Absorbable Collagen Hemostatic Sponge

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The Food and Drug Administration (FDA) is announcing its approval of the application by Bioetica, Inc., Westbrook, ME, on behalf of Coletica, S. A., Lyon, France, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of HEMOSTAGENE Absorbable Collagen Hemostatic Sponge. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of August 15, 1995, of the approval of the application.