ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM

Device Classification Name

colonic irrigation system

510(k) Number K033149
Device Name ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
Applicant
ULTIMATE CONCEPTS, INC.
3722 ave. sausalito
irvine, 
CA 
92606

Applicant Contact grace holland
Correspondent
ULTIMATE CONCEPTS, INC.
3722 ave. sausalito
irvine, 
CA 
92606

Correspodent Contact grace holland
Regulation Number 876.5220
Classification Product Code
KPL  
Date Received 09/30/2003
Decision Date 03/23/2004
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