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

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..

Clearance details

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

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