Concord/Portex · Class II · Cleared May 3, 1991
| K-number | K911037 |
| Device name | SAFETY NEEDLE SHEATH, MODIFICATION |
| Applicant | Concord/Portex |
| Product code | FMI |
| Device class | Class II |
| Decision date | May 3, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 880.5570 |
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