The following data is part of a premarket notification filed by Bionomy, Inc. with the FDA for Pruitt Irrigation And Occlusion Catheter.
| Device ID | K844094 |
| 510k Number | K844094 |
| Device Name: | PRUITT IRRIGATION AND OCCLUSION CATHETER |
| Classification | Catheter, Irrigation |
| Applicant | BIONOMY, INC. P.O. BOX 270882 Tampa, FL 33688 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul BIONOMY, INC. P.O. BOX 270882 Tampa, FL 33688 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-18 |
| Decision Date | 1984-11-29 |