510(k) K902053
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1990
- Date Received
- May 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fixation Accessory
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type