The following data is part of a premarket notification filed by Gnali Bocia S.r.l. with the FDA for Bio Fluff System.
| Device ID | K201861 |
| 510k Number | K201861 |
| Device Name: | Bio Fluff System |
| Classification | Colonic Irrigation System |
| Applicant | Gnali Bocia S.R.L. Via Brescia, 41/M-N Lumezzane, IT 25065 |
| Contact | Katy Gnali |
| Correspondent | Katy Gnali Gnali Bocia S.R.L. Via Brescia, 41/M-N Lumezzane, IT 25065 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-06 |
| Decision Date | 2022-03-02 |