OLYMPUS VIDEO URETEROSCOPE, NTSC

Device Classification Name

ureteroscope and accessories, flexible/rigid

510(k) Number K033651
Device Name OLYMPUS VIDEO URETEROSCOPE, NTSC
Applicant
OLYMPUS WINTER & IBE GMBH
two corporate center dr.
melville, 
NY 
11747 -3157

Applicant Contact tina steffanie-oak
Correspondent
OLYMPUS WINTER & IBE GMBH
two corporate center dr.
melville, 
NY 
11747 -3157

Correspodent Contact tina steffanie-oak
Regulation Number 876.1500
Classification Product Code
FGB  
Date Received 11/20/2003
Decision Date 01/30/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No