IRRIGATION SETS


Device Classification Name

system, irrigation, urological

510(k) Number K023808
Device Name IRRIGATION SETS
Original Applicant
INTERNATIONAL MEDSURG CONNECTION
p.o. box 848
grayslake, 
IL 
60030

Original Contact michele h vovolka
Regulation Number 876.5130
Classification Product Code
LJH  
Subsequent Product Code
HRX  
Date Received 11/14/2002
Decision Date 03/10/2003
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