The following data is part of a premarket notification filed by Dura Pharmaceuticals, Inc. with the FDA for Pari I.s.-2.
| Device ID | K896984 |
| 510k Number | K896984 |
| Device Name: | PARI I.S.-2 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DURA PHARMACEUTICALS, INC. P.O. BOX 2209 Ramona, CA 92065 |
| Contact | Tom Evangelisti |
| Correspondent | Tom Evangelisti DURA PHARMACEUTICALS, INC. P.O. BOX 2209 Ramona, CA 92065 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-11 |
| Decision Date | 1990-03-09 |