K090002 is an FDA 510(k) clearance for the ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A. This device is classified as a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II - Special Controls, product code KPO).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on August 7, 2009, 217 days after receiving the submission on January 2, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K090002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2009 |
| Decision Date | August 07, 2009 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |