AIRVIEW MINI OWIE DICK TEST PACK— 510(k) K133204

Name: FDA 510(k) clearance K133204
Creator: U.S. Food and Drug Administration
Published: 2014-05-05

Substantially Equivalent

Crosstex International

FDA 510(k) clearance K133204 for AIRVIEW MINI OWIE DICK TEST PACK, Substantially Equivalent on 2014-05-05. Applicant: Crosstex International. Device class: 2.

Clearance details

Applicant: Crosstex International
Product code: Code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2013-10-17
Decision date: 2014-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rush, NY, 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.