510(k) K772401
K772401 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "LAP BOARD W/RIM". The FDA issued a decision of Substantially Equivalent on January 5, 1978. The device falls under product code IMX (Board, Lap, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1978
- Date Received
- December 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Board, Lap, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3910
- Review Panel
- PM
- Submission Type