The following data is part of a premarket notification filed by Airxpanders, Inc. with the FDA for Aeroform Tissue Expander, Smooth.
| Device ID | K191138 |
| 510k Number | K191138 |
| Device Name: | AeroForm Tissue Expander, Smooth |
| Classification | Carbon Dioxide Gas Controlled Tissue Expander |
| Applicant | AirXpanders, Inc. 3047 Orchard Parkway San Jose, CA 95134 |
| Contact | Belinda Pinedo |
| Correspondent | Belinda Pinedo AirXpanders, Inc. 3047 Orchard Parkway San Jose, CA 95134 |
| Product Code | PQN |
| CFR Regulation Number | 878.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-30 |
| Decision Date | 2019-07-11 |