510(k) K041952
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2005
- Date Received
- July 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type