Cleared Traditional

K800118 - CHICK SURGICAL TABLE
(FDA 510(k) Clearance)

Feb 1980
Decision
18d
Days
Class 1
Risk

K800118 is an FDA 510(k) clearance for the CHICK SURGICAL TABLE. This device is classified as a Table, Operating-room, Non-electrical (Class I - General Controls, product code FWY).

Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1980, 18 days after receiving the submission on January 18, 1980.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K800118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1980
Decision Date February 05, 1980
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FWY — Table, Operating-room, Non-electrical
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4950