510(k) K823405
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1983
- Date Received
- November 15, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Toe, Constrained, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3720
- Review Panel
- OR
- Submission Type