Universal Light Handle Cover, Light Handle Cover— 510(k) K150532

Name: FDA 510(k) clearance K150532
Creator: U.S. Food and Drug Administration
Published: 2015-09-22

Substantially Equivalent

Key Surgical, Inc.

FDA 510(k) clearance K150532 for Universal Light Handle Cover, Light Handle Cover, Substantially Equivalent on 2015-09-22. Applicant: Key Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Key Surgical, Inc.
Product code: Code FTA
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2015-03-02
Decision date: 2015-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.