Regulatory Technology Services LLC / K121035 Trade / OLYMPUS / OperationOte Color PWDTCWoDope Co / FUJIFILM Medical Systems U.S.A. Inc. / Fuji / /
Country
United States / /
Event
FDA Phase / /
IndustryTerm
endoscopic equipment / peripheral equipment / video processor / peripheral devices / manufacturing practice requirements / ultrasonic processor / manufacturing practice / medical electrical systems / marketed device / Internet address http /
NaturalFeature
IDown Forceps channel / /
Organization
Division of Ohithalic / Neurlogical and Ear / Food and Drug Administration / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Division of Postinarket Surveillance / Ear / Nose and Throat Devices Office / Center for Devices / Division of Ophthalmic / Neurological / and Ear / Center for Devices and Radiological Health / Division of Ohithalic / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Ophthalmic / /
Person
Mark Job / B. Eydelman / Gina Walljasper / Adult Cardiac Pediatric Cardiac Intravascular (Cardiac) / / /
Position
General / Director / cio / Director / Quality and Regulatory Compliance / /
Product
Fuj ifilm's ultrasonic processor / Fuj / sterile water / Federal Food / /
K210Y FUJIFILM JUN[removed]k) Summary