Device |
apparatus, exhaust, surgical |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General Hospital |
Product Code | FYD |
Premarket Review |
Infection Control and Plastic Surgery Devices
(DHT4B)
Infection Control and Plastic Surgery Devices
(DHT4B)
|
Submission Type |
510(k)
|
Regulation Number |
878.5070
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|
|
|