Operating Room Light Handle Adapter— 510(k) K142386

Name: FDA 510(k) clearance K142386
Creator: U.S. Food and Drug Administration
Published: 2014-09-29

Substantially Equivalent

Litex Manufacturing, Inc.

FDA 510(k) clearance K142386 for Operating Room Light Handle Adapter, Substantially Equivalent on 2014-09-29. Applicant: Litex Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant: Litex Manufacturing, Inc.
Product code: Code FTA
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2014-08-27
Decision date: 2014-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

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