FDA Product Code
FDA Product Code PQN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3510
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191138 | AeroForm Tissue Expander, Smooth | Airxpanders, Inc. | 2019-07-11 | Special | PDF ↗ |
| K170075 | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) | Airxpanders, Inc. | 2017-04-03 | Traditional | PDF ↗ |
| DEN150055 | AeroForm Tissue Expander System | Airxpanders, Inc. | 2016-12-21 | Direct | — |
Product code PQN · Class II · General, Plastic Surgery. Data: openFDA.