MAC 150E OPTHALMIC CHAIR— 510(k) K864574

Name: FDA 510(k) clearance K864574
Creator: U.S. Food and Drug Administration
Published: 1986-12-15

Substantially Equivalent

Koken Mfg Company, Inc.

FDA 510(k) clearance K864574 for MAC 150E OPTHALMIC CHAIR, Substantially Equivalent on 1986-12-15. Applicant: Koken Mfg Company, Inc.. Device class: 1.

Clearance details

Applicant: Koken Mfg Company, Inc.
Product code: Code HME
Device class: Class 1
Regulation: 21 CFR 886.1140
Advisory panel: Ophthalmic
Date received: 1986-11-20
Decision date: 1986-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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