510(k) K911982
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1991
- Date Received
- May 3, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3690
- Review Panel
- OR
- Submission Type