CareLink Corp.; Premarket Approval of CareFoneSUPTM Home Uterine Activity Monitoring System, Model 2001

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The Food and Drug Administration (FDA) is announcing its approval of the application by CareLink Corp., Santa Ana, CA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of CareFone TM Home Uterine Activity Monitoring System, Model 2001. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 29, 1995, of the approval of the application.