510(k) K822022
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1982
- Date Received
- July 9, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Limb Brace
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type