Cleared Traditional

DR.500O OPERATING TABLE

K864295 · Koken Mfg Company, Inc. · General & Plastic Surgery

Nov 1986

Decision

19d

Days

Class 1

Risk

About This 510(k) Submission

K864295 is an FDA 510(k) clearance for the DR.500O OPERATING TABLE, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by Koken Mfg Company, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 19, 1986, 19 days after receiving the submission on October 31, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K864295 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 1986
Decision Date	November 19, 1986
Days to Decision	19 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—