HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM— 510(k) K080966

Name: FDA 510(k) clearance K080966
Creator: U.S. Food and Drug Administration
Published: 2008-08-06

Substantially Equivalent

Aoti , Ltd.

FDA 510(k) clearance K080966 for HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM, Substantially Equivalent on 2008-08-06. Applicant: Aoti , Ltd.. Device class: 2.

Clearance details

Applicant: Aoti , Ltd.
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 2008-04-04
Decision date: 2008-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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