Device |
laser, ent microsurgical carbon-dioxide |
Regulation Description |
Ear, nose, and throat microsurgical carbon dioxide laser. |
Regulation Medical Specialty |
Ear Nose & Throat |
Review Panel |
Ear Nose & Throat |
Product Code | EWG |
Premarket Review |
Office of Device Evaluation
(ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices
(DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
|
Submission Type |
510(k)
|
Regulation Number |
874.4500
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Recognized Consensus Standard
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|
|
|