510(k) K822651
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1982
- Date Received
- September 2, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Hand, And Components
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type