510(k) K053494
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2006
- Date Received
- December 15, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type