510(k) K954443
Clearance Details
- Decision
- SN ()
- Decision Date
- January 31, 1996
- Date Received
- September 25, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type