COOK INJECTION NEEDLE


Device Classification Name

endoscopic injection needle, gastroenterology-urology

510(k) Number K022484
Device Name COOK INJECTION NEEDLE
Original Applicant
COOK UROLOGICAL, INC.
1100 west morgan st.
p.o. box 227
spencer, 
IN 
47460

Original Contact debbie schmitt
Regulation Number 876.1500
Classification Product Code
FBK  
Date Received 07/29/2002
Decision Date 10/25/2002
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