The following data is part of a premarket notification filed by Colon Therapeutics with the FDA for Jimmy John Iii Rectal Nozzel, Model Cit.
| Device ID | K972455 |
| 510k Number | K972455 |
| Device Name: | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT |
| Classification | Colonic Irrigation System |
| Applicant | COLON THERAPEUTICS 6249 25TH ST. P.O. BOX 1401 Groves, TX 77619 |
| Contact | Jim J Girouard |
| Correspondent | Jim J Girouard COLON THERAPEUTICS 6249 25TH ST. P.O. BOX 1401 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 | 1997-07-01 |
| Decision Date | 1997-09-09 |