Gems Vitrification Set, Gems Warming Set— 510(k) K162409

Name: FDA 510(k) clearance K162409
Creator: U.S. Food and Drug Administration
Published: 2017-05-24

Substantially Equivalent

Genea Biomedx Pty, Ltd.

FDA 510(k) clearance K162409 for Gems Vitrification Set, Gems Warming Set, Substantially Equivalent on 2017-05-24. Applicant: Genea Biomedx Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Genea Biomedx Pty, Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2016-08-29
Decision date: 2017-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

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