New Hampshire Avenue Document Control Center / Court Allendale / / /
IndustryTerm
surgical site / announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / /
Organization
Division of Postmarket Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / office of Surveillance / FDA / Mark N. Melkerson Acting Director Division / Surgical Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Public Health Service Food and Drhg Administration / Device Evaluation Center for Devices and Radiological Health Enclosure Stoyker Spine / /
Person
Silver Spring / Peter D. Rumni / Tina Mornak / Tina Momak / / /
Stryker Spine - LITJ Decompression System - Light Cable Trad itional 510(k) Premnarket Notification