The following data is part of a premarket notification filed by Bci, Inc. with the FDA for Irrigator, Body Cavity.
| Device ID | K781918 |
| 510k Number | K781918 |
| Device Name: | IRRIGATOR, BODY CAVITY |
| Classification | Tray, Irrigation, Sterile |
| Applicant | BCI, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EYN |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-13 |
| Decision Date | 1979-02-15 |