USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8


Device Classification Name

ureteroscope and accessories, flexible/rigid

510(k) Number K023358
Device Name USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
Original Applicant
ACMI CORPORATION
136 turnpike rd.
southborough, 
MA 
01772

Original Contact terrence sullivan
Regulation Number 876.1500
Classification Product Code
FGB  
Subsequent Product Code
FBN  
Date Received 10/07/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No