| K-number | K772032 |
| Device name | GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP |
| Applicant | Harleco |
| Product code | CJE |
| Device class | Class II |
| Decision date | Nov 17, 1977 |
| Decision | Substantially Equivalent |
| Regulation | 862.1050 |
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