STERIS corporation / Vaporized 712 Sterilization Processes STERIS Corporation / PRO maX (Lumen Non Lumen and Flexible Cycles) Low Temperature Sterilization Systems / HP / FDA Regulatory Affairs STERIS Corporation / V-PROT maX (Flexible Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems / /
Event
FDA Phase / /
IndustryTerm
media changes / announcements concerning your device / predicate device / media ampoule / qjua lity systems / marketed predicate devices / healthcare providers / /
Organization
Division of Anesthesiology / Division of Postmaurket Surveillance / M.B.A. Director Division of Anesthesiology / Center for Devices and Radiological Health / Anesthesiology / General H-ospital / Infection Control and Dental Devices Office / office of Device Evaluation / office of Surveillance / FDA / Device Evaluation Center for Devices / DEPARTMENT OF HEALTH / Center for Devices / /
Person
Anthony D. Watson / Robert F. Sullivan / / /
Position
Senior Director / Director / General / sterilizer / /
Product
Sterilant/ Injection / Olympus E-3 Digital Camera / Sterilant/ Sterilization Cycle Injection / AND/OR #Exposure Injections / Federal Food / Verify / /
14 K1033311S001 STERIS Response to[removed]Request for Additional Information Verify Biological Indicator Challenge Pack for Vaporized H2 Sterilization Processes SEP