Cleared Traditional

K850251 - ROTALOK SURGICAL HAND TABLE
(FDA 510(k) Clearance)

K850251 · Fairleigh Dickinson Laboratories, Inc. · General & Plastic Surgery device
Feb 1985
Decision
37d
Days
—
Risk

K850251 is an FDA 510(k) clearance for the ROTALOK SURGICAL HAND TABLE..

Submitted by Fairleigh Dickinson Laboratories, Inc. (Allendale, US). The FDA issued a Cleared decision on February 28, 1985, 37 days after receiving the submission on January 22, 1985.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K850251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date February 28, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —