K933818 is an FDA 510(k) clearance for the GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER. This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II - Special Controls, product code KDI).
Submitted by C.G.H. Medical, Inc. (Lakewood, US). The FDA issued a Cleared decision on January 25, 1995, 539 days after receiving the submission on August 4, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K933818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1993 |
| Decision Date | January 25, 1995 |
| Days to Decision | 539 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |