The following data is part of a premarket notification filed by Allegiance Healthcare Corporation with the FDA for Small Volume Nebulizer.
| Device ID | K023602 |
| 510k Number | K023602 |
| Device Name: | SMALL VOLUME NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ALLEGIANCE HEALTHCARE CORPORATION 1500 WAUKEGAN RD., BLDG. WM Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols ALLEGIANCE HEALTHCARE CORPORATION 1500 WAUKEGAN RD., BLDG. WM Mcgaw Park, IL 60085 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-28 |
| Decision Date | 2003-05-01 |
| Summary: | summary |