Device |
gown, surgical |
Regulation Description |
Surgical apparel. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General Hospital |
Product Code | FYA |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
Submission Type |
510(k)
|
Regulation Number |
878.4040
|
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
|
Recognized Consensus Standards
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |