The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Dry Acid Dissolution Units.
| Device ID | K131611 |
| 510k Number | K131611 |
| Device Name: | FRESENIUS DRY ACID DISSOLUTION UNITS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST Waltham, MA 02451 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2013-08-29 |