| K-number | K896984 |
| Device name | PARI I.S.-2 |
| Applicant | Dura Pharmaceuticals, Inc. |
| Product code | CAF |
| Device class | Class II |
| Decision date | Mar 9, 1990 |
| Decision | Substantially Equivalent for Some Indications |
| Regulation | 868.5630 |
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