The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate.
| Device ID | K192209 |
| 510k Number | K192209 |
| Device Name: | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate |
| 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 | 2019-08-14 |
| Decision Date | 2020-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861101467 | K192209 | 000 |
| 00840861101450 | K192209 | 000 |
| 00840861101443 | K192209 | 000 |
| 00840861101436 | K192209 | 000 |
| 00840861101429 | K192209 | 000 |
| 00840861101412 | K192209 | 000 |
| 00840861101405 | K192209 | 000 |
| 00840861101399 | K192209 | 000 |