510(k) K232677
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2024
- Date Received
- September 1, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pessary, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3575
- Review Panel
- OB
- Submission Type