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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30889483587168 | K023602 | 000 |
| 30889483599093 | K023602 | 000 |
| 30889483571976 | K023602 | 000 |
| 30889483571044 | K023602 | 000 |
| 30889483571051 | K023602 | 000 |
| 30889483571068 | K023602 | 000 |
| 30889483571075 | K023602 | 000 |
| 30889483571082 | K023602 | 000 |
| 30889483571099 | K023602 | 000 |
| 30889483571105 | K023602 | 000 |
| 30889483571150 | K023602 | 000 |
| 30889483571174 | K023602 | 000 |
| 30889483571198 | K023602 | 000 |
| 30889483571938 | K023602 | 000 |
| 30889483571235 | K023602 | 000 |
| 30889483583351 | K023602 | 000 |