510(k) K962244
Clearance Details
- Decision
- SN ()
- Decision Date
- August 9, 1996
- Date Received
- June 11, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device Class
- Class II
- Regulation Number
- 888.3650
- Review Panel
- OR
- Submission Type