510(k) K010303
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2001
- Date Received
- December 5, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Stiffness, Cartilage, Arthroscopic
- Device Class
- Class II
- Regulation Number
- 888.1100
- Review Panel
- OR
- Submission Type