510(k) DEN150055
- Device
- AeroForm Tissue Expander System
- Applicant
- Airxpanders, Inc.
- 510(k) number
- DEN150055
- Product code
- PQN
- Decision
- Unknown (DENG)
- Decision date
- 2016-12-21
- Date received
- 2015-12-07
- Regulation
- 878.3510
- Classification name
- Carbon Dioxide Gas Controlled Tissue Expander
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Robin` Bush
- Address
- 1047 Elwell Ct. Palo Alto CA US 94303 94303
FDA Registration Numbers#
- 2953359
Source Documents#
510(k) summary PDF not indicated by FDA