device manufacturers / metal instruments / long gas / manufacturing practices / chemical sterilants / specified gas / manufacturing site / device manufacturer / gas plasma / /
Organization
U.S. Department of Health and Human Services / Radiological Health office of Device Evaluation Preface Public Comment Comments / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / Division of Dental / Infection Control and General Hospital Devices / Division of Management Systems and Policy / office of Device Evaluation / Food and Drug Administration Center for Devices / Radiological Health / FDA / office of Human Resources and Management Services / /
Person
Timothy A. Ulatowski / / /
Position
Governor / Director / Branch Chief / Deputy Director for Science and Regulatory Policy / Assistant / referring division director / /
Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA