510(k) K010298
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2001
- Date Received
- January 31, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Micromanipulators And Microinjectors, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6150
- Review Panel
- OB
- Submission Type