510(k) K915776
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1992
- Date Received
- December 24, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Prosthesis
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type