WOODBINE XT350, XENON ARC LIGHT SOURCE— 510(k) K922820

Name: FDA 510(k) clearance K922820
Creator: U.S. Food and Drug Administration
Published: 1992-09-02

Substantially Equivalent

Woodbine Ptical Corp.

FDA 510(k) clearance K922820 for WOODBINE XT350, XENON ARC LIGHT SOURCE, Substantially Equivalent on 1992-09-02. Applicant: Woodbine Ptical Corp.. Device class: 2.

Clearance details

Applicant: Woodbine Ptical Corp.
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1992-06-11
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wrentham, MA, 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.