Device |
mesh, surgical, non-absorbable, facial implants for plastic surgery |
Definition |
For reinforcement of soft tissue where weakness exists in facial plastic surgery. |
Physical State |
A plastic polymer mesh; either square, rectangular, or round. |
Technical Method |
A non-absorbable mesh that reinforces soft tissue. |
Target Area |
Face |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | OWR |
Premarket Review |
Infection Control and Plastic Surgery Devices
(DHT4B)
Infection Control and Plastic Surgery Devices
(DHT4B)
|
Submission Type |
510(k)
|
Regulation Number |
878.3300
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |