The following data is part of a premarket notification filed by Bellco Srl with the FDA for Rapido Hollow-fibre Dialyzers.
| Device ID | K160558 |
| 510k Number | K160558 |
| Device Name: | RAPIDO HOLLOW-FIBRE DIALYZERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BELLCO Srl via Camurana 1 Mirandola, IT 41037 |
| Contact | Giuseppe Tomasini |
| Correspondent | Barry Sall PAREXEL Consulting, LLC 195 West Street Waltham, MA 02451 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-11-18 |
| Summary: | summary |