The following data is part of a premarket notification filed by Ultimate Concepts, Inc. with the FDA for Colonic And Enema Nozzle.
| Device ID | K051344 |
| 510k Number | K051344 |
| Device Name: | COLONIC AND ENEMA NOZZLE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-23 |
| Decision Date | 2005-08-18 |
| Summary: | summary |