The following data is part of a premarket notification filed by Palex Intl. Sa with the FDA for Palex Irrigation Set.
| Device ID | K904586 |
| 510k Number | K904586 |
| Device Name: | PALEX IRRIGATION SET |
| Classification | Irrigator, Ostomy |
| Applicant | PALEX INTL. SA CARRETERA DE TERRASSA, 121 08191 RUBI' (BARCELONA) Spain, ES |
| Contact | Martin A Jordan |
| Correspondent | Martin A Jordan PALEX INTL. SA CARRETERA DE TERRASSA, 121 08191 RUBI' (BARCELONA) Spain, ES |
| Product Code | EXD |
| CFR Regulation Number | 876.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-09 |
| Decision Date | 1990-12-28 |