The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for 2008k2 Hemodialysis Machine.
| Device ID | K153449 |
| 510k Number | K153449 |
| Device Name: | 2008K2 Hemodialysis Machine |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| 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 | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-30 |
| Decision Date | 2016-04-26 |
| Summary: | summary |