510(k) K040717
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2004
- Date Received
- March 19, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Labware, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6160
- Review Panel
- OB
- Submission Type