510(k) K843518
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1984
- Date Received
- September 5, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Surgical Instrument, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type