The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Naturalyte Dry Bicarbonate Concentrate (rx-10 Bag), Naturalyte Dry Bicarbonate Concentrate (rx-12 Bag), Naturalyte Dry Bicarbonate Concentrate (carton).
| Device ID | K191474 |
| 510k Number | K191474 |
| Device Name: | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| 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 | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-04 |
| Decision Date | 2020-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861101969 | K191474 | 000 |
| 00840861101955 | K191474 | 000 |
| 00840861101948 | K191474 | 000 |