The following data is part of a premarket notification filed by Airxpanders, Inc. with the FDA for Aeroform Tissue Expander (v3.0), Aeroform Dosage Controller (v1.5).
| Device ID | K170075 |
| 510k Number | K170075 |
| Device Name: | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) |
| Classification | Carbon Dioxide Gas Controlled Tissue Expander |
| Applicant | AirXpanders, Inc. 1047 Elwell Ct. Palo Alto, CA 94303 |
| Contact | Belinda Pinedo |
| Correspondent | Belinda Pinedo AirXpanders, Inc. 1047 Elwell Ct. Palo Alto, CA 94303 |
| Product Code | PQN |
| CFR Regulation Number | 878.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-04-03 |
| Summary: | summary |