The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Surdial Dx Hemodialysis System.
| Device ID | K182940 |
| 510k Number | K182940 |
| Device Name: | Surdial DX Hemodialysis System |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Nipro Medical Corporation 3150 NW 107th Ave. Doral, FL 33172 |
| Contact | Jessica Oswald-mcleod |
| Correspondent | Jessica Oswald-mcleod Nipro Medical Corporation 3150 NW 107th Ave. Doral, FL 33172 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-23 |
| Decision Date | 2019-07-19 |