COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS— 510(k) K082363

Name: FDA 510(k) clearance K082363
Creator: U.S. Food and Drug Administration
Published: 2009-04-29

Substantially Equivalent

William A. Cook Australia Pty. , Ltd.

FDA 510(k) clearance K082363 for COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS, Substantially Equivalent on 2009-04-29. 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: 2008-08-18
Decision date: 2009-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eight Mile Plains, Qld, 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.