510(k) K992308
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1999
- Date Received
- July 9, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6100
- Review Panel
- OB
- Submission Type