Spire Biomedical, Inc. · Class II · Cleared Jan 29, 2007
| K-number | K063431 |
| Device name | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 |
| Applicant | Spire Biomedical, Inc. |
| Product code | MSD |
| Device class | Class II |
| Decision date | Jan 29, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 876.5540 |
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