Cleared Traditional

K893045 - A-DEC PRIORITY 1005 CHAIR (FDA 510(k) Clearance)

Jul 1989
Decision
81d
Days
Class 1
Risk

K893045 is an FDA 510(k) clearance for the A-DEC PRIORITY 1005 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 July 14, 1989, 81 days after receiving the submission on April 24, 1989.

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

Submission Details

510(k) Number K893045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date July 14, 1989
Days to Decision 81 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