FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
AeroForm Tissue Expander System
K Number: DEN150055
·
Decision Dec 21, 2016
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
3
Review Days
380
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Basic Information
- Device Name
- AeroForm Tissue Expander System
- K Number
- DEN150055
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 878.3510
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Airxpanders, Inc.
- Date Received
- December 7, 2015
- Decision Date
- December 21, 2016
- Product Code
- PQN
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PQN | Carbon Dioxide Gas Controlled Tissue Expander | FDA class 2 | General, Plastic Surgery |
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