The following data is part of a premarket notification filed by Ultimate Concepts, Inc. with the FDA for Ultimate Professional Continuous Flow Colonic System.
| Device ID | K033149 |
| 510k Number | K033149 |
| Device Name: | ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM |
| Classification | Colonic Irrigation System |
| Applicant | ULTIMATE CONCEPTS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland ULTIMATE CONCEPTS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-03-23 |
| Summary: | summary |