The following data is part of a premarket notification filed by Viratek, Inc. with the FDA for Spag-2 Aerosol Generator W/use Of Virazole.
| Device ID | K870051 |
| 510k Number | K870051 |
| Device Name: | SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-06 |
| Decision Date | 1987-10-06 |