510(k) K915139
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1992
- Date Received
- November 13, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- OR
- Submission Type