COOK NEPHROSTOMY DILATION BALLOON CATHETER SET


Device Classification Name

catheter, nephrostomy

510(k) Number K024050
Device Name COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
Original Applicant
COOK UROLOGICAL, INC.
1100 west morgan st.
p.o. box 227
spencer, 
IN 
47460

Original Contact debbie schmitt
Classification Product Code
LJE  
Date Received 12/09/2002
Decision Date 02/27/2003
Decision

substantially equivalent

(SESE)

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No