The following data is part of a premarket notification filed by Amici, Inc. with the FDA for The Swirler Aerosol System.
| Device ID | K952893 |
| 510k Number | K952893 |
| Device Name: | THE SWIRLER AEROSOL SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AMICI, INC. 518 VINCENT ST. Spring City, PA 19475 |
| Contact | Michael Bono |
| Correspondent | Michael Bono AMICI, INC. 518 VINCENT ST. Spring City, PA 19475 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-23 |
| Decision Date | 1995-11-03 |