AeroForm Tissue Expander, Smooth— 510(k) K191138
Substantially EquivalentAirxpanders, Inc.
FDA 510(k) clearance K191138 for AeroForm Tissue Expander, Smooth, Substantially Equivalent on 2019-07-11. Applicant: Airxpanders, Inc.. Device class: 2.
Clearance details
- Applicant
- Airxpanders, Inc.
- Product code
- Code PQN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3510
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code PQN
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