510(k) K800602
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1980
- Date Received
- March 17, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Semi-Constrained
- Device Class
- Class II
- Regulation Number
- 888.3800
- Review Panel
- OR
- Submission Type