United Contact Lens; Premarket Approval of UCL-55 and UCL-55 TORIC (Ocufilcon C) Soft (Hydrophilic) Contact Lenses

摘要

The Food and Drug Administration (FDA) is announcing its approval of the application by United Contact Lens (UCL), Lynwood, WA, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the UCL-55 and UCL-55 TORIC (ocufilcon C) Soft (hydrophilic) Contact Lenses. The devices are to be manufactured under an agreement with N & N Contact Lens International, Inc., Lynwood, WA, which has authorized UCL to incorporate information contained in the approved premarket approval application (PMA) and related supplements for the SOFTOUCH and SOFTOUCH TORIC (ocufilcon C) Soft (hydrophilic) Contact Lenses. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant by letter on March 7, 1994, of the approval of the application.