Janice M. Hogan Hogan Lovells US LLP / Covidien / OCT K120116 Trade / /
Country
United States / / /
Event
FDA Phase / / /
IndustryTerm
tw~o predicate systems / monopolar electrosurgical device / announcements concerning your device / predicate devices / cleared ablation systems / ablationi systems / sterile device / coagulation device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / marketed devices / Internet address http /
MedicalCondition
thermal necrosis / sterility / chronic study / /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / I/A Director Division of Surgical / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use Statement / Division Sinof Division of Surgical / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic / and Restorative Devices Office / SERF / /
Person
Silver Spring / Katharine M Stohiman / / /
Position
Vice President of Regulatory Affairs Email / General / /
510(k) Summary Company: Thermedical 150 Bear Hill Road Waltham, MA[removed]