K1 13 821 Trade / LiOCO Ltd. / Transonic Systems Inc. / /
Country
United States / /
Event
Product Issues / Product Recall / / /
IndustryTerm
announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /
MedicalTreatment
hemodialysis / /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Cardiovascular Devices Office / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use Statement / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /
Person
Naveen Thuramalla / Silver Spring / Thumnlla / / /