510(k) DEN150008
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 2, 2015
- Date Received
- February 23, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture, Intravaginal, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6165
- Review Panel
- OB
- Submission Type
Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.