Division of Postmarket Surveillance / HUMAN SERVICES Pusblic Health Service / Food and Drug Administration / OFFICE OF DEVICE EVALUATION / office of Surveillance / Device Evaluation Center for Devices and Radiological Health Indications for Use / Cardiovascular Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /
K[removed]K) SUMMARY In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR[removed], this information serves as a 510Ok