DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER


Device Classification Name

catheter, retention type, balloon

510(k) Number K024010
Device Name DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
Original Applicant
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP
15 hampshire st.
mansfield, 
MA 
02048

Original Contact david a olson
Regulation Number 876.5130
Classification Product Code
EZL  
Subsequent Product Code
KOD  
Date Received 12/04/2002
Decision Date 06/11/2003
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