The following data is part of a premarket notification filed by Colon Therapeutics with the FDA for Modified Jimmy John Iii.
| Device ID | K870127 |
| 510k Number | K870127 |
| Device Name: | MODIFIED JIMMY JOHN III |
| Classification | Colonic Irrigation System |
| Applicant | COLON THERAPEUTICS 2729 UPTON DR. Port Arthur, TX 77642 |
| Contact | Jimmy Girouard |
| Correspondent | Jimmy Girouard COLON THERAPEUTICS 2729 UPTON DR. Port Arthur, TX 77642 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-09 |
| Decision Date | 1987-03-17 |