The following data is part of a premarket notification filed by Project Marketing with the FDA for 56 Series Aerosol Generator.
| Device ID | K980074 |
| 510k Number | K980074 |
| Device Name: | 56 SERIES AEROSOL GENERATOR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PROJECT MARKETING 112 CAVISTON WAY Cary, NC 27560 |
| Contact | Terry O'brien |
| Correspondent | Terry O'brien PROJECT MARKETING 112 CAVISTON WAY Cary, NC 27560 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-08 |
| Decision Date | 1998-06-12 |