Spire Biomedical, Inc. · Class II · Cleared Apr 19, 2004
| K-number | K040509 |
| Device name | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 |
| Applicant | Spire Biomedical, Inc. |
| Product code | MSD |
| Device class | Class II |
| Decision date | Apr 19, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 876.5540 |
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