Device |
aspirator, ultrasonic |
Review Panel |
Obstetrics/Gynecology |
Product Code | MGI |
Premarket Review |
Office of Device Evaluation
(ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices
(DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
|
Submission Type |
Contact ODE
|
Device Class |
3
|
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 |
Not Third Party Eligible |
|
|