medical device manufacturer / post-amendments device / medical devices / predicate device / manufacturing practices / regulations to require such devices / marketed device / energy source / pre-amendments device / combination products / /
MedicalCondition
injury / illness / disease / /
Organization
U.S. Department of Health and Human Services / office of Communication / Outreach and Development / Food and Drug Administration / Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment You / office of Device Evaluation / Center for Devices and Radiological Health / Division of Dockets Management / Food and Drug Administration Center for Devices / office of Combination Products / Task Force on the Utilization of Science / Center for Biologics Evaluation and Research / / /
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]