510(k) K982841
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1998
- Date Received
- August 12, 1998
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type