The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Hemoflow F3 And F4 Dialyzers.
| Device ID | K190459 |
| 510k Number | K190459 |
| Device Name: | Hemoflow F3 And F4 Dialyzers |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-26 |
| Decision Date | 2019-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100023 | K190459 | 000 |
| 10840861100016 | K190459 | 000 |