510(k) K973736
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1997
- Date Received
- October 1, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- OR
- Submission Type