The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Irrigation System.
| Device ID | K840268 |
| 510k Number | K840268 |
| Device Name: | IRRIGATION SYSTEM |
| Classification | Irrigator, Ostomy |
| Applicant | COLOPLAST A/S 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EXD |
| CFR Regulation Number | 876.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-23 |
| Decision Date | 1984-04-05 |