The following data is part of a premarket notification filed by Fresenius Medical Care, North America - Renal Ther with the FDA for Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand Assembly.
| Device ID | K133299 |
| 510k Number | K133299 |
| Device Name: | ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER 920 WINTER ST. Waltham, MA 02451 |
| Contact | Denise M Oppermann |
| Correspondent | Denise M Oppermann FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER 920 WINTER ST. 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 | 2013-10-25 |
| Decision Date | 2014-07-07 |
| Summary: | summary |