K896757 is an FDA 510(k) clearance for the GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS. This device is classified as a System, Dialysate Delivery, Single Patient (Class II - Special Controls, product code FKP).
Submitted by Gambro, Inc. (Williamsburg, US). The FDA issued a Cleared decision on August 30, 1990, 272 days after receiving the submission on December 1, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K896757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1989 |
| Decision Date | August 30, 1990 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKP — System, Dialysate Delivery, Single Patient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |