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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K162409
Device Name Gems Vitrification Set, Gems Warming Set
Applicant
GENEA BIOMEDX PTY LTD
LEVEL 2, 321 KENT STREET
SYDNEY,  AU 2000
Applicant Contact Kea Dent
Correspondent
DONAWA LIFESCIENCE CONSULTING
PIAZZA ALBANIA 10
ROME,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number884.6180
Classification Product Code
MQL  
Date Received08/29/2016
Decision Date 05/24/2017
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 Yes
Predetermined Change
Control Plan Authorized		 No
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