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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 K180304
Device Name Geri Embryo Incubator and Geri Dish
Applicant
Genea Biomedx Pty Ltd
Level 2, 321 Kent Street
Sydney,  AU 2000
Applicant Contact Kea Dent
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number884.6120
Classification Product Code
MQG  
Subsequent Product Codes
MQK   MTX  
Date Received02/02/2018
Decision Date 04/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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