The following data is part of a premarket notification filed by Isopure, Corp. with the FDA for Isopure Dry Acid Dissolution System.
| Device ID | K191093 |
| 510k Number | K191093 |
| Device Name: | Isopure Dry Acid Dissolution System |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | Isopure, Corp. 11851 Plantside Drive Louisville, KY 40299 |
| Contact | Kevin Gillespie |
| Correspondent | Kevin Gillespie Isopure, Corp. 11851 Plantside Drive Louisville, KY 40299 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-25 |
| Decision Date | 2020-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852456007115 | K191093 | 000 |
| 00852456007108 | K191093 | 000 |