Sydney IVF Gamete Buffer— 510(k) K153478

Name: FDA 510(k) clearance K153478
Creator: U.S. Food and Drug Administration
Published: 2016-08-15

Substantially Equivalent

William A. Cook Australia Pty. , Ltd.

FDA 510(k) clearance K153478 for Sydney IVF Gamete Buffer, Substantially Equivalent on 2016-08-15. Applicant: William A. Cook Australia Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: William A. Cook Australia Pty. , Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2015-12-02
Decision date: 2016-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eight Mile Plains, AU

Download summary PDF View on FDA.gov ↗

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