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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessory, assisted reproduction
510(k) Number K171736
Device Name Geri Embryo Incubator and Geri Dish
Genea Biomedx Pty Ltd
Level 2, 321 Kent Street
Sydney,  AU 2000
Applicant Contact Kea Dent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number884.6120
Classification Product Code
Date Received06/12/2017
Decision Date 11/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No