510(k) K971303
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 1997
- Date Received
- April 8, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cup, Menstrual
- Device Class
- Class II
- Regulation Number
- 884.5400
- Review Panel
- OB
- Submission Type
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.