510(k) K884412
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1988
- Date Received
- October 20, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Ultrasonic Instruments
- Device Class
- Class U
- Regulation Number
- Review Panel
- NE
- Submission Type