OXYBOX SYSTEM— 510(k) K023456

Substantially Equivalent

Oxyfast Corporation

FDA 510(k) clearance K023456 for OXYBOX SYSTEM, Substantially Equivalent on 2003-02-24. Applicant: Oxyfast Corporation. Device class: 2.

Clearance details

Applicant: Oxyfast Corporation
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 2002-10-15
Decision date: 2003-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.