The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Elisio-h Hemodialyzer, Elisio-m Hemodialyzer.
| Device ID | K131935 |
| 510k Number | K131935 |
| Device Name: | ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Contact | Carolyn George |
| Correspondent | Carolyn George NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-12-20 |
| Summary: | summary |