Cleared Traditional

MAC 150E OPTHALMIC CHAIR

K864574 · Koken Mfg Company, Inc. · Ophthalmic
Dec 1986
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K864574 is an FDA 510(k) clearance for the MAC 150E OPTHALMIC CHAIR, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by Koken Mfg Company, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 15, 1986, 25 days after receiving the submission on November 20, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.

Submission Details

510(k) Number K864574 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1986
Decision Date December 15, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HME — Chair, Ophthalmic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1140

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