Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit— 510(k) K152682

Name: FDA 510(k) clearance K152682
Creator: U.S. Food and Drug Administration
Published: 2016-05-05

Substantially Equivalent

Willian A. Cook Australia Pty, Ltd.

FDA 510(k) clearance K152682 for Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit, Substantially Equivalent on 2016-05-05. Applicant: Willian A. Cook Australia Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Willian A. Cook Australia Pty, Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2015-09-18
Decision date: 2016-05-05
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.