LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER— 510(k) K053321

Name: FDA 510(k) clearance K053321
Creator: U.S. Food and Drug Administration
Published: 2006-01-19

Substantially Equivalent

Xodus Medical, Inc.

FDA 510(k) clearance K053321 for LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER, Substantially Equivalent on 2006-01-19. Applicant: Xodus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Xodus Medical, Inc.
Product code: Code FTA
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2005-11-30
Decision date: 2006-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Kensington, PA, 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.