510(k) K822632
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1982
- Date Received
- August 31, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Joint, Elbow, External Limb Component, Powered
- Device Class
- Class I
- Regulation Number
- 890.3420
- Review Panel
- PM
- Submission Type