COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH


Device Classification Name

image, illumination, fiberoptic, for endoscope

510(k) Number K072521
Device Name COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
Applicant
COOK UROLOGICAL, INC.
1100 west morgan st.
spencer, 
IN 
47460

Applicant Contact cindy foote
Correspondent
COOK UROLOGICAL, INC.
1100 west morgan st.
spencer, 
IN 
47460

Correspodent Contact cindy foote
Regulation Number 876.1500
Classification Product Code
FFS  
Subsequent Product Codes
FAJ   FED   FGA   FGB   GCJ  
Date Received 09/07/2007
Decision Date 11/20/2007
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