510(k) K953432
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1995
- Date Received
- July 21, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Surgical Instrument, Pneumatic Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type