Fortune Medical Instrument Corp. · Class II · Cleared Mar 31, 1998
| K-number | K980919 |
| Device name | ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER |
| Applicant | Fortune Medical Instrument Corp. |
| Product code | EZL |
| Device class | Class II |
| Decision date | Mar 31, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
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