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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 K170498
Device Name Gems Oocyte Retrieval Buffer ORB-20, ORB-50
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 Number884.6180
Classification Product Code
Date Received02/17/2017
Decision Date 09/28/2017
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