The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Elisio-h And Elisio-m Hemodialyzers.
| Device ID | K122347 |
| 510k Number | K122347 |
| Device Name: | ELISIO-H AND ELISIO-M HEMODIALYZERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NIPRO MEDICAL CORPORATION 6695 RIVER CREST PT Suwanee, GA 30024 |
| Contact | Carolyn George |
| Correspondent | Carolyn George NIPRO MEDICAL CORPORATION 6695 RIVER CREST PT Suwanee, GA 30024 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-03 |
| Decision Date | 2013-05-01 |
| Summary: | summary |