The following data is part of a premarket notification filed by Colon Therapeutics with the FDA for Jimmy John Iii Rectal Nozzle.
| Device ID | K973256 |
| 510k Number | K973256 |
| Device Name: | JIMMY JOHN III RECTAL NOZZLE |
| Classification | Colonic Irrigation System |
| Applicant | COLON THERAPEUTICS 209 MAIN AVE. Groves, TX 77619 |
| Contact | Jim Girouard |
| Correspondent | Jim Girouard COLON THERAPEUTICS 209 MAIN AVE. Groves, TX 77619 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1997-09-29 |