Cleared Traditional

K903454 - A-DEC DECADE 1010 CHAIR (FDA 510(k) Clearance)

Oct 1990
Decision
85d
Days
Class 1
Risk

K903454 is an FDA 510(k) clearance for the A-DEC DECADE 1010 CHAIR. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on October 24, 1990, 85 days after receiving the submission on July 31, 1990.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K903454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 24, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code KLC — Chair, Dental, With Operative Unit
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.6250