The following data is part of a premarket notification filed by Colonic Plus with the FDA for Colonic Plus Regular, Small, And Straight Shape Hydrokit.
| Device ID | K180800 |
| 510k Number | K180800 |
| Device Name: | Colonic Plus Regular, Small, And Straight Shape Hydrokit |
| Classification | Colonic Irrigation System |
| Applicant | Colonic Plus 73-925 Hwy 111, Ste. L Palm Desert, CA 92260 |
| Contact | Rosa Alvarez |
| Correspondent | Rosa Alvarez Colonic Plus 73-925 Hwy 111, Ste. L Palm Desert, CA 92260 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-27 |
| Decision Date | 2018-06-01 |
| Summary: | summary |