The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Pureflux-l Hemodialyzer.
| Device ID | K122952 |
| 510k Number | K122952 |
| Device Name: | NIPRO PUREFLUX-L HEMODIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | NIPRO MEDICAL CORPORATION 6695 RIVER CREST PT Suwanee, GA 30024 |
| Contact | Carolyn Geaorge |
| Correspondent | Carolyn Geaorge NIPRO MEDICAL CORPORATION 6695 RIVER CREST PT Suwanee, GA 30024 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-25 |
| Decision Date | 2013-12-04 |
| Summary: | summary |