510(k) K780296
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1978
- Date Received
- February 21, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Board, Scooter, Prone
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type