| K-number | K011544 |
| Device name | HADGEL, 4 GRAM/SYRINGE |
| Applicant | Seikagaku Corp. |
| Product code | LYA |
| Device class | Class I |
| Decision date | Aug 15, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 874.4780 |
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