K850251Substantially Equivalent

Rotalok Surgical Hand Table

Name: K850251 Rotalok Surgical Hand Table
Creator: Fairleigh Dickinson Laboratories, Inc.
Published: 1985-02-28
License: https://open.fda.gov/license/

Fairleigh Dickinson Laboratories, Inc., Allendale NJ / Traditional, Substantially Equivalent

FDA source

K850251 is the FDA 510(k) clearance record for ROTALOK SURGICAL HAND TABLE, cleared for Fairleigh Dickinson Laboratories, Inc. on 1985-02-28. FDA records list 7 510(k) clearances for Fairleigh Dickinson Laboratories, Inc., from 1985-02-28 to 1990-01-29. As of 2026-09-10, FDA records show no recalls naming K850251.

Clearance record

Decision date: 1985-02-28
Received: 1985-01-22 (37 days to decision)
Review panel: Unknown
Applicant: Fairleigh Dickinson Laboratories, Inc. 6 Pearl Ct., Allendale NJ
Third party review: No