K121886 Trade / Savina 300 / Dräger Medical GmbH / 1 PSC Publishing / Draeger Medical GmbH / / /
Event
FDA Phase / /
Facility
General Hospital / New Hampshire Avenue Document Control Center / /
IndustryTerm
announcements concerning your device / manufacturing practice requirements / gas supply / marketed predicate devices / manufacturing practice / Internet address http /
MedicalTreatment
Continuous Positive Airway Pressure / /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / General Hospital / Device Evaluation Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / CDRH’s office of Surveillance / M.S. Director Division of Anesthesiology / /
Person
Anya C. Harry / M.D. Tejashri Purohit-Sheth / Silver Spring / Tejashri Purohit-Sheth / Ulrich Schröder / Erin I. Keith / / /
Position
Director Regulatory Affairs Tel. No. / Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith / Director Regulatory & Clinical Affairs Moislinger Allee / Director Regulatory & Clinical Affairs Tel. No. / Deputy Director DAGRID/ODE/CDRH FOR / /
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