The following data is part of a premarket notification filed by Viratek, Inc. with the FDA for (spag) Model Spag-2 6000 Series.
| Device ID | K871427 |
| 510k Number | K871427 |
| Device Name: | (SPAG) MODEL SPAG-2 6000 SERIES |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Contact | Staffa, Phd |
| Correspondent | Staffa, Phd VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-09 |
| Decision Date | 1987-10-06 |