| Device |
pessary, vaginal |
| Regulation Description |
Vaginal pessary. |
| Regulation Medical Specialty |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
| Product Code | HHW |
| Submission Type |
510(k)
|
| Regulation Number |
884.3575
|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence
|
|
|
Third Party Review
|
Accredited Persons
|
|
|