The following data is part of a premarket notification filed by Dura Pharmaceuticals, Inc. with the FDA for Pari Inhalierboy Type 37.80 Double Insulated.
| Device ID | K894555 |
| 510k Number | K894555 |
| Device Name: | PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| 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 | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1990-01-24 |