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Examen
Device Rac Mutiple Choice Exam Questions With Answers
DEVICE RAC MUTIPLE CHOICE EXAM QUESTIONS WITH ANSWERS 
 
 
.510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except: 
 
A) High Flux Hemodialyzer 
B) Blood specimen collection device 
C) Piston syringe 
D) Cardiopulmonary bypass blood tubing - Answer-B 
 
.A 510(k) submission for any Class III device MUST include: 
A. Clinical results summary 
B. Hazards analysis evaluation 
C. Stability evaluation 
D. Cer...