Cleared Traditional

K842625 - CUSTOM NEURO TRAY (FDA 510(k) Clearance)

Sep 1984
Decision
76d
Days
Risk

K842625 is an FDA 510(k) clearance for the CUSTOM NEURO TRAY..

Submitted by Deroyal Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984, 76 days after receiving the submission on July 6, 1984.

This device falls under the Neurology FDA review panel.

Submission Details

510(k) Number K842625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1984
Decision Date September 20, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary

Device Classification

Product Code
Device Class