Spire Biomedical, Inc. · Class II · Cleared Feb 12, 2007
| K-number | K063441 |
| Device name | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 |
| Applicant | Spire Biomedical, Inc. |
| Product code | MSD |
| Device class | Class II |
| Decision date | Feb 12, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 876.5540 |
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