Gambro Renal Products · Class II · Cleared Oct 10, 2001
| K-number | K010985 |
| Device name | GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L |
| Applicant | Gambro Renal Products |
| Product code | KDI |
| Device class | Class II |
| Decision date | Oct 10, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 876.5860 |
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