Gambro Renal Products, Inc. · Class II · Cleared Dec 21, 2010
| K-number | K100451 |
| Device name | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 |
| Applicant | Gambro Renal Products, Inc. |
| Product code | MPB |
| Device class | Class II |
| Decision date | Dec 21, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 876.5540 |
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