510(k) K020274
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2002
- Date Received
- January 28, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Hemi-, Ulnar
- Device Class
- Class II
- Regulation Number
- 888.3810
- Review Panel
- OR
- Submission Type