510(k) K082857
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2009
- Date Received
- September 29, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Special Grade
- Device Class
- Class II
- Regulation Number
- 890.3880
- Review Panel
- PM
- Submission Type