Sydney IVF Culture Oil— 510(k) K170257

Name: FDA 510(k) clearance K170257
Creator: U.S. Food and Drug Administration
Published: 2017-02-24

Substantially Equivalent

William A. Cook Australia Pty. , Ltd.

FDA 510(k) clearance K170257 for Sydney IVF Culture Oil, Substantially Equivalent on 2017-02-24. 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: 2017-01-27
Decision date: 2017-02-24
Decision: Substantially Equivalent
Clearance type: Special
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.