The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius 2008t Hemodialysis Machine.
| Device ID | K113427 |
| 510k Number | K113427 |
| Device Name: | FRESENIUS 2008T HEMODIALYSIS MACHINE |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2011-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861100903 | K113427 | 000 |