510(k) K850251
K850251 is an FDA 510(k) premarket notification submitted by Fairleigh Dickinson Laboratories, Inc. for the device "ROTALOK SURGICAL HAND TABLE". The FDA issued a decision of Substantially Equivalent on Feb 28, 1985. Fairleigh Dickinson Laboratories, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 1985
- Date Received
- Jan 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No